Welcome to the BioFrontera Inc. 3rd Quarter 2026 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 Lutham Partners Investor Relations. Please go ahead.

Good morning and welcome to BioFrontera's third quarter 2026 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. Forward-looking statements on today's call include statements regarding the timing and success of the commercial launch of amylose of superficial basal cell carcinoma, the company's supplemental new drug application for actinic keratosis on the extremities, neck, and trunk, the effects of the International Trade Commission orders, the company's remediation plan, and the Roto-Lex LED XLC, the outcome of pending appeals and patents proceedings, the company's liquidity, its ability to continue as a going concern, and its plans to address that condition, and the company's compliance with NASDAQ continued listing standards. All risks and uncertainties are detailed in and are qualified by the cautionary statements contained in the buyer Fronteras press releases and SEC filings, including the company's quarterly report on the Form 10-Q for the quarter ended September 30, 2026, which the company expects to file later today, and the company's annual report on the Form 10-K for the year ended December 31, 2025. Also, this conference call contains time sensitive information that is accurate only as of the date of this live broadcast. Frontera 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 available on the company's website at www.biofrontera-us.com under the investor relations section. Please note management will be referencing adjusted EBITDA, a non-GAAP financial measure defined as net loss excluding interest expense, net income and other non-recurring or non-cash items, including changes in fair value of warrant liabilities and of the related party investment, patent remediation expense and ITC-related inventory write-downs and stock-based compensation. With that said, I would now like to turn the call over to Hermann Luebbert, CEO, Chairman and Founder of BioFrontera. Hermann, please proceed.

Sir, is your line on mute, perhaps?

Yes, I was on mute. Thank you. Well, thanks, Ben, and thanks, everyone, for joining us this morning. Do you hear me now? Yes, sir, loud and clear. Great. So the third quarter changed what the company is able to sell and to whom. With two things happening within five days of each other in September... and I want to start with both of them before we get to the numbers. On September 9, the FDA approved amylose photodynamic therapy for the treatment of superficial basal cell carcinoma in adults. That makes amylose the first PDT approved in the United States to treat a skin cancer. Until now, our label has been limited to mild to moderate actinic keratosis on the face and scalp. We now have a second indication. Superficial basal cell carcinoma represents up to 20% of all basal cell carcinomas, the most common cancers in the United States. Many of these patients are today treated surgically. Amelus PDT gives dermatologists a non-surgical option with a favorable cosmetic outcome that they can deliver to the rat with the rat lamp that is already in the office. Furthermore, we believe that the approval to treat a skin cancer will convince more doctors to introduce amylose PDT as a routine treatment in their offices and purchase one of our red lamps. Then, on September 14, four days after the superficial BCC approval, the U.S. Customs and Border Protection ruled that our redesigned large field lamp which we called Rodolat XLC does not infringe the asserted claims of the Doosan Pharmaceutical Patents and is not subject to the exclusion order issued by the International Trade Commission or ITC earlier in the year. Let me put that into context. The ITC orders took effect on July 6th. From that date, we could not import or sell the original Rodolet XL and we could not sell Amelus for use with it. Customers whose only lamp was the Rodolet XL were temporarily unable to buy Amelus from us. But in light of the September 14 CBP ruling, We can now sell the Rodolet XLC, providing our prior Rodolet XL customers with a large five-panel lamp that is unrelated to the ITC orders to go alongside our smaller bay of Rodolet lamp, which is similarly not affected by the ITC orders. And of course, we can continue selling Amelus to any customers who have either an XLC or a bay of Rodolet lamp. By September, the number of customers ordering from us was back to the level of a year ago. I said on our last call that we will not allow our commercial plan to depend on winning in court, and that is how it turned out. We designed around the patents, obtained the favorable ruling, had no objections from the FDA, and are working through the remediation of the affected lamps in the field which we expect to be substantially complete by the end of the second quarter of 2027. We will furthermore file our appeals with the Federal Circuit, both of the Commission's determination and of the Patent Office Director's decision. I will not speculate on the timing or outcome of those appeals. This matter did cost us in the quarter. Fred will take you through the detail, but legal fees, remediation costs, and inventory write-ons tied to the ITC matter are the main reason our operating loss was larger than in the second quarter. I regard most of this as the cost of getting to the other side of the problem. Now to the pipeline, because it is the clearest picture of how this company grows in 2027 and beyond. First, superficial basal cell carcinoma. We expect to begin commercializing Amalus for SBCC with a full launch in the first quarter of 2027 after receiving FDA feedback on our anticipated marketing material. The launch goes into our existing installed base of lambs and our existing dermatology call points. George will describe the preparation. Second, actinic keratosis on the extremities, neck, and trunk. In early October, we submitted our supplemental new drug application to expand the amylose label beyond the face and scalp to treat AK on the entire body. FDA has confirmed a PDUFA date of August 5, 2027, and initiated its preliminary review. AK is in most cases a UV light induced disease and occurs on all body parts frequently exposed to the sun. Such body parts can be larger than face and scalp and we applied for a treatment field of up to 240 square centimeters supported by the positive phase III results we announced earlier this year. SPDT on larger areas is often associated with more pain We furthermore filed with FDA an illumination protocol expected to reduce this pain. With approximately 58 million American adults having at least one AK lesion, treating the extremities, neck and trunk meaningfully expands the use of Hermelus in every one of our customers' offices and on every lamp already in the field. So the picture is this. One year ago, We had one indication and a transfer price that took 25-35% of our revenue away. Today, we own the US assets, we have two approved indications, a third filed, and a LAMP portfolio that is clear of the ITC exclusion order. Each of the indications runs through the same LAMPs and the same sales force. I would now like to turn the call over to George Jones, our Chief Commercial Officer. George?

Thank you, Hermann, and good morning, everybody. Product revenues in the third quarter were $9.1 million, an increase of approximately 30% year over year. AMLU's unit volume grew approximately 23% with the balance of the growth coming from a price increase we implemented in the fourth quarter of 25 as well as increased lamb sales that occurred during the quarter. In the third quarter, we sold approximately 25,120 tubes of amylose, up 23% from 20,380 in Q3 of 2025. I'd like to drill a little deeper into the results. In June into early July, ahead of the ICC orders taking effect, a number of customers purchased Amalus earlier than they otherwise would have. Because of those purchases, we had a fast start to the quarter. We ensured customers received ample supply of Amalus to treat their patients while we worked on the remediation efforts Hermann spoke about earlier. This higher July was simply a shift in timing, and we believe that this inventory was largely worked through by the end of Q3. It is important to remember that the ITC orders only impacted approximately 200 customers and 25% of our Amaluz sales volume. And the rest of our customers could continue to purchase Amaluz as normal. Moving on to lamps. We ended the quarter with an installed base of 853 lamps across 742 different dermatology offices. This includes approximately 12 of the small Roto LED lamps that were sold during Q3 to customers that wanted a biofrontera light, red light, but didn't want to wait until the XLC was available. This is good news. We began processing exchanges of the XLC lamps upon receiving Customs and Border Protection approval. They began shipping during Q3, but were not installed until early October. As I think back on the quarter, I'm especially pleased by the progress we made on the remediation efforts Hermann mentioned. By placing both Roto-LED and XLC lamps in offices that previously purchased the XL lamps, we have been able to significantly reduce the percentage of Ameluz sales impacted by the ITC order from approximately 25% of Ameluz volume to only 10% of Ameluz sales volume today. Turning to sales execution, I could not be more impressed with this Biofrontera team. They've never met a challenge that they haven't been able to overcome. we're seeing significant momentum in our business. All key sales metrics were positive year over year, both in Q3 as well as the first nine months of the year. In Q3, orders were up 6% year over year, tubes per order were up 21% and new locations buying Amelus increased by 11 or 39% year over year. Looking at 2026 to date, tubes of Amelus were up 23% Number of orders were up 13% and tubes for order were up 10% year over year. Furthermore, in 2026, we've seen lower turnover within our sales force as well as a positive impact of our new inside sales efforts, which is contributing to our overall results. Moving on to SBCC and launch preparation. I'd like to start by saying there's been significant early interest in learning more about Amiluz for superficial basal cell carcinoma and a clear belief from our customers that this new indication provides meaningful differentiation between Amiluz red light PDT and our competitors. As we mentioned earlier, we're launching using a phased approach for which phase one is underway. I'd like to call out some phase one highlights for you. We've begun talking to KOLs about the SBTC data and received great feedback. We've confirmed our reimbursement strategy. As Hermann mentioned, we've submitted our marketing claims to the FDA for their feedback. Our full product training is beginning this week, and our launch meeting is scheduled for mid-January. Importantly, to support the launch, I want to reiterate that we'll be using our current sales infrastructure and calling on many of the same dermatology offices were already equipped and ready to expand their utilization and offer their patients an innovative non-surgical option to treat their superficial basal cell carcinoma. We're looking forward to the fourth quarter and finishing 2026 strong.

With that, I'll turn the call over to Fred Leffler, our Chief Financial Officer.

Fred?

Thank you, George, and good morning, everyone. I'll walk through our results for the third quarter. The first nine months ended September 30th, 2026. All comparisons are to the same prior year period unless otherwise noted. The full reconciliation of GAAP to non-GAAP measures is included in our press release that we filed earlier this morning and is available on our website. Revenues for the third quarter were $9.1 million compared to $7.0 million last year, an increase of 29.8%. As George described, unit volume grew 23.3% or approximately $1.6 million with a balance from the fourth quarter 2025 price increase and higher device sales. Substantially, all of that volume growth reflects approximately $1.6 million of orders placed in early July ahead of the IPC effective date The increase reflects AMALU's unit volume growth of approximately $5.5 million including about $3.6 million from accelerated order timing and approximately $0.7 million from the fourth quarter 2025 price increase. Cost of revenues for the quarter were $2.3 million compared with $2.0 million producing a gross profit of $6.7 million and gross margin of $74.4 million compared to $70.7 million the year before in 2025. and improvement of approximately 370 basis points. The improvement comes from the cost structure we put in place with the strategic transaction that Hermann mentioned earlier, which is AMALU's direct cost plus a 12% earn out on net revenue. The third quarter margin is lower than the roughly 80% we reported in the first half for a couple reasons. First, LAMP and device costs were $0.4 million higher driven by higher Excel sales and $0.3 million of Roto LED lamp inventory write downs, including a $0.2 million write down of Excel long-term raw materials and work in process. For the nine months, gross margin was 78.0% compared to 67.7% in the prior year. Selling general and administrative expenses, including the related party line, were $12.5 million for the quarter compared to $10.4 million the year before, an increase of $2.1 million. The main drivers were a $1.1 million increase in general and administrative expense, mostly $0.9 million of higher legal fees related to the ITC matter and $0.7 million of costs in land manufacturing and in regulatory and product affairs, which are functions we took over with the strategic transaction last year. And $0.5 million of higher direct sales expense, namely commissions on higher AMALUs volumes, which were partly offset by $0.3 million of decreases in related party SG&A. for the nine months SG&A was $33.2 million compared to $29.6 million, an increase of $3.5 million. Research and development expenses were $0.5 million for the quarter compared to $0.9 million and $1.8 million for the nine months compared to $2.9 million, reflecting the substantial completion of our clinical trials. Patent remediation expense was $0.3 million in the quarter and $0.7 million for the nine months. Let me give you the full cost of the ITC matter to date outside of the legal fees since it sits in more than one line. Through September 30th, we have recognized total charges of $1.1 million made up of $0.6 million of accrued remediation costs and $0.5 million of inventory write downs. Of the remediation costs, $0.2 million was settled with used in the remediation program and 0.4 is paid or payable in cash. Net loss for the quarter was 6.4 million or 42 cents per share compared with a net loss of 6.6 million or 62 cents per share last year. For the nine months, net loss was 11.8 million or 89 cents per share compared with 16.2 million in 2025 for $1.67 per share. Adjusted EBITDA for the quarter was negative 5.5 million compared with negative 6.0 million. An adjusted EBITDA margin of negative 60.9% against a negative margin of 80.7% last year. For the nine months, adjusted EBITDA was negative 9.3 million compared to negative 15.5 million, a margin of negative 29.7% against negative 63.0%. The third quarter is seasonally our weakest, and this year it also absorbed some ITC legal spend, which was not backed back into adjusted EBITDA. Turning to the balance sheet and liquidity, as of September 30th, 2026, we had cash and cash equivalents of 3.2 million compared with 6.4 million at December 31st, 2025. Cash used in operating activities for the nine months of 2026 was 3.2 million down from 11.0 million a year ago. Total liabilities were 21.7 million compared to 18.1 million at year-end 2025. Our only outstanding indebtedness is about 4.7 million of convertible notes net maturing in November of 2027. We have no bank or long-term debt. As a result of Q3, our stockholders deficit was 0.2 million at September 30th, 2026. So we do not currently meet minimum stockholders equity requirements of NASDAQ, but we expect to and many more. I want to address the going concern disclosure directly as well. As described in our Form 10-Q, which we will file later today, management has concluded that substantial doubt exists about the company's ability to continue as a going concern for at least 12 months from the issuance of our Form 10-Q. Our plan, in terms of compliance, is to continue as a going concern for at least 12 months. Our plan to mitigate has four parts. They'll be laid out in the queue. Continuing to grow AMALU's revenue with Q4 typically our strongest quarter, including supported by the FBCC launch while controlling expenses. Obtaining and drawing on a working line of credit The next 1.0 million milestone payments from our ZEPI divestiture, which we expect in December and which depends on the purchaser achieving certain milestones and, if necessary, raising additional capital through equity or debt. Some of these are not within our control and these plans have not alleviated the substantial doubts. With that overview of our financial results, we are now ready to take questions from our covering analysts. Operator?

Thank you. We will now begin the question and answer session from our covering analysts. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. And as a final reminder, if you'd like to ask a question, please press star than one at this time. And our first question today comes from Bruce Jackson at StoneX. Please go ahead.

Hi, good morning, and thanks for taking my questions. I just wanted to look at the operating expense profile going into the fourth quarter. So third quarter had several special charges. Where do you see that core rate for cost of goods sold? And so what type of gross margins are we going to be looking at? And then with the SG&A, maybe you could give us kind of a rough indicator of where that might shake out.

Yeah. Thanks for asking. So on the gross profit, I expect that to be back around our 80% mark. Nothing to my knowledge for the first quarter should push that down like the charges did in Q3. With regarding to SG&A, Generally, we've been doing, aside from the legal points that I mentioned, we've been doing an excellent job of managing our costs, doing what we need to do to support the business. So I expect that to continue and we'll manage the legal costs as needed.

Okay.

You mentioned that you're putting together the reimbursement strategy for the superficial basal cell carcinoma indication. Is reimbursement going to be available when you launch that? And do you have a rough idea of what that might be?

Yeah, I'll take that. We believe that there will be a clear path to reimbursement upon launch of the indication. We're in the market right now working with some key customers I'll say kind of confirming that strategy and relative to exactly how much it's going to be for the customers. The tubes of amylose will be reimbursed as normal via the J code and then the procedure codes we're finalizing kind of what we think that's gonna be for the customer.

Okay, got it. Thank you very much.

Thank you. That concludes our question and answer session. I'd like to turn the conference back over to management for any closing remarks.

Yeah, thank you, Operator, and thank you to everyone who joined us today. Let me leave you with three takeaways. First, amylose is now the only PDT drug in the U.S. approved for skin cancer. Superficial basal cell carcinoma is our second US indication, and we begin commercializing it later this quarter and into the first quarter of 2027. Second, the ITC matter is no longer limiting which customers we can serve. The XLC is cleared, our customers are ordering again, and the remediation is on a defined path. The third quarter shows the cost of getting here and we are not hiding from it. Our cash position requires discipline and Fred has told you how we plan to address it. What has changed is what we have to sell. Two indications today and a third filed, all delivered through the lamps and the sales force already in place. I want to thank our entire team for their dedication and hard work. I also want to thank our shareholders Thank you for your continued support. Have a wonderful day. Thank you. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect and have a wonderful day.