Biofrontera Inc.

Welcome to the BioFrontera Inc. Third Quarter 2025 Financial Results and Business Update Conference Call. All participants will be in a 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. Please note, this event is being recorded. I would now like to turn the conference over to Ben Shamsian with Lithlum Partners Investor Relations. Please go ahead.

Thank you. Good morning and welcome to Biofrantera Inc's third 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 Biofrantera'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, the risks and uncertainties associated with the company's business. All risks and uncertainties are detailed 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 the live broadcast, November 13, 2025. BioFrontera undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of the 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 just issued yesterday. Please note, management will be referring, will be referencing adjusted EBITDA, 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 said, I would like to turn the call over to Herman Lubert, CEO, Chairman, and Founder of BioFrontera. Herman, please proceed.

Thank you, Ben. And my thanks to everyone who is joining us this morning. Before I begin with my company update, I want to address our 2025 revenues until September 30th. Our year-to-date revenues were approximately flat to the same period in 2024. This is a wonderful achievement as we have offered few buying opportunities in 2025 and we did not have the equivalent price increase that we had on October 1st, 2024. A price increase presents buy-in opportunities to customers, and lacking these opportunities, our revenues in the third quarter of this year were 22% lower than in Q3 last year. However, this is a transient effect which has begun to normalize in recent weeks, And as a result, we anticipate strong revenue growth in the fourth quarter in 2025 and consequently throughout 2025. We remain on track to achieve our full-year sales objectives. Fred Leffler, our CFO, will discuss the numbers in a few minutes in much more detail. Now with that said, I would like to focus on our recent achievements and upcoming catalysts for revenue and profitability growth. We continue to make great progress in advancing BioFrontera as a premier dermatology company. Our revamped sales approach, centered on refined customer segmentation, a more focused commercial strategy, and data-driven sales execution has proven effective, as shown by the stable revenues without the booster of a price increase. Both physicians and patients gain a deeper understanding of Amelus PDT's clinical value and efficacy. The installed base of rhodolat lamps continues to expand, supporting recurring high-marching cells of Amelus gel for years to come. For those new to BioFrontera, the Amelus PDT treatment currently has indication only for the treatment of actinic keratosis or AK on the face and scalp. AKs are precancerous skin lesions which may progress to potentially fatal squamous cell carcinomas. Our therapy consists of the amylose gel in combination with photodynamic therapy, or PDT, using our Rodolet lamps. As of now, we have approximately 750 Rodolet lamps installed in dermatology offices. This expanding platform provides us with an incredible opportunity to meaningfully accelerate revenues once Amaluz is approved for more indications. Our clinical pipeline continues to advance and further strengthen the long-term potential of the Amaluz franchise. In the coming weeks, we will submit a new FDA application for Amaluz to treat superficial basal cell carcinoma. This represents an important expansion opportunity for amyloose with commercialization expected in the fourth quarter, 2026. We also completed patient enrollment in our phase three trial, evaluating amyloose for actinic keratosis on the extremities, neck and trunk, and in our phase two B trial for moderate to severe acne vulgaris. AKs are ultraviolet light induced lesions and while most occur on face and scalp, a significant number will also appear on other body parts that are frequently exposed to the sun. Adding the treatment of such lesions to our label will add tremendous opportunity as physicians want to be able to treat a case wherever they occur without worrying about reimbursement difficulties which they may face if they treat outside of the FDA label. Acne vulgaris, is a chronic inflammatory skin condition affecting the pellucidaceous 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. For patients under 40 years of age, acne is the most frequent reason to see a dermatologist. For those older than 40, Actinic erythrosis is the most frequent diagnosis in dermatology offices. Together, these indications highlight our ambition to grow the clinical and commercial potential of Amalus across multiple high-value dermatologic indications. Earlier this year, we received patent approval for the new improved formulation of Amalus, extending our patent protection through December 2043. BioFrontera is the only company that has organized FDA-controlled clinical studies for PDT and dermatology in the U.S. in recent years, and the extended patent life is relevant to recover the investment and profit from the resulting possibilities. We recently completed our transformational agreement with BioFrontera AG. By acquiring all U.S. rights, approvals, and patents for Amalus and Rodolet, we now have full control over our most important assets, from production to commercialization. This transaction is expected to significantly enhance our gross margins and strengthen our long-term profitability. The new royalty structure, 12% when U.S. MLO's revenue is below $65 million per year, and 15% when it exceeds that threshold, replaces the prior transfer pricing model of 25% to 35%, creating meaningful financial leverage as we continue to grow the Amelus brand in the US market. Already on June 1 last year, when we took over the responsibility for all clinical trials, we negotiated a reduced transfer price, reflected in the cost of revenue for the first six months, which were about $2.6 million lower in the previous year, mostly due to the reduced transfer price, lower than in the previous year. Shifting now to the royalty model will not only dramatically decrease our cost of sales further, but also significantly delay the time of the payments. Transfer prices are due when we buy a product. Royalties become into effect after such products are sold into the market. As part of the transaction, we also secured an $11 million investment from well-established healthcare-focused institutional investors. Combined with the recent addition of the proceeds from the divestment of the Xeppy antibiotic cream, This capital positions us with a clear runway to sustained growth and profitability. We did complete the sale of our CEPI license last week, receiving $3 million at closing with the possibility of an additional $7 million as certain milestones are achieved. CEPI has been an inactive product for years due to manufacturing difficulties and therefore the divestment will not result in the loss of a portion of our sales. We believe the proceeds from this and the financing I mentioned a moment ago and of our continued commercial execution will bring us to cash flow breakeven for fiscal year 2026. 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 talk about. At this time, I'm pleased to turn the call over to Fred to go through the financial details of the third quarter and first nine months. Fred?