BFRI

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 10 a.m. ET Chief Executive Officer, Chairman, and Founder - Hermann Luebbert Chief Commercial Officer - George Jones Chief Financial Officer - Fred Leffler Operator: Welcome to the Biofrontera Second Quarter 2026 Financial Results and Business Update Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Ben Shamsian with Lytham Partners Investor Relations. Please go ahead. Behnam Shamsian: Good morning and welcome to Biofrontera Inc.'s Second 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 the risks and uncertainties associated with the company's business. The forward-looking statements on today's call include statements regarding the company's full year 2026 revenue goals, the anticipated effects of the International Trade Commission orders and the company's remediation plan, the company's liquidity and the ability to continue as a going concern, the outcome of pending proceedings and the potential approval and launch of new indications for Ameluz. All risks and uncertainties are detailed and are qualified by the cautionary statements contained in Biofrontera's press release and SEC filings, including the company's quarterly reports on Form 10-Q for the quarter ended June 30, 2026, 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. 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 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 taxes, depreciation, and amortization, and certain other non-recurring or non-cash items, including changes in fair value of warrant liabilities, panel remediation expense, and the related inventory write-down 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. Hermann Lubbert: Yes, thank you, Ben. And thank you to everyone joining us this morning. The second quarter of 2026 was the strongest operating Q2, and the first half year was the strongest H1 in the company's history as a standalone U.S. business. Net product revenue grew 33% to $12 million. Gross margin reached approximately 80% compared to approximately 71% a year ago. And adjusted EBITDA came to $200,000 of breakeven against a loss of $5.1 million in Q2 of last year. These strong results in Q2, which for us is traditionally a weaker quarter, are not just one quarter out of the ordinary. They reflect the build-up of a commercial organization that is executing along with the expense discipline across the entire organization. We are seeing the pace of reorders from our physician accounts accelerate, which reflects the strength of underlying demand generation. George and Fred will take you through the details in a moment. The results also further reflect the strategic transaction we completed in October 2025, which gave Biofrontera full ownership and control of all U.S. rights, approvals, and patents for the Ameluz and RhodoLED portfolio, and replaced a transfer pricing model of 25% to 35% of revenue with a 12% earn-out on net sales. Before diving into the business, I want to address the International Trade Commission matter because I expect it is on your minds. On May 6, the Commission issued its final determination finding a violation of Section 337 with respect to two Sun Pharmaceutical patents covering certain components of our RhodoLED XL lamp. In their decision, the Commission contradicted the conclusion of the U.S. Patent Office's Trial and Appeal Board, which, in agreement with our belief, had previously found every challenged claim of one of the patents unpatentable. The Commission issued a limited exclusion order and cease and desist orders which took effect on July 7. We can no longer import or sell the current RhodoLED XL lamp in the United States. And we are restricted from selling Ameluz for use with the RhodoLED XL. Three things you should understand about the scope of this. First, this affects the XL lamp. It does not in any way affect the original BF-RhodoLED lamp, which represents the substantial majority of our installed lamp base. Physicians using those lamps are unaffected and Ameluz sales to accounts with the BF-RhodoLED lamp continue normally. Second, we have a remediation plan designed to allow selling a modified version of our XL lamp that is outside the scope of both Sun Pharmaceutical patents. We recorded approximately $500,000 in the first quarter as our best estimate of the remediation cost, and that estimate has not changed. Because the substantial majority of our installed lamp base is unaffected, and we expect to get approval for providing a modified version of the RhodoLED XL that is outside the patent space, we expect the exclusion order to affect the timing of orders rather than total demand. Third and finally, we are not finished contesting this. We retain the right to appeal the Commission's determination to the Federal Circuit. I will not speculate on how those proceedings will resolve or when. What I will tell you is that while pursuing every avenue available to us, our commercial plan does not depend on winning any of them. Our commercial success will be because of our continued dedication to doctors and patients, as well as investment in developing Ameluz and PDT to be used in more indications. Now let me turn to the clinical pipeline, because it is the clearest picture of how this company will grow in 2027 and beyond. First, superficial basal cell carcinoma. The FDA accepted filing of our supplemental New Drug Application for Ameluz PDT for the treatment of superficial basal cell carcinoma with a PDUFA target date of September 28, 2026. If approved, Ameluz will be the first PDT in the United States approved for the treatment of cancerous skin tumors, and we expect a full launch in Q1 of 2027 with initial outreach to customers during Q4 of 2026. That launch would go directly into our existing installed base of BF-RhodoLED lamps and our existing dermatology call points. The commercial infrastructure is already in place. Second,actinic keratosis on the extremities, neck, and trunk. Earlier this year, we announced positive and statistically significant top-line Phase III results, with the study meeting its primary endpoint. This data supports our plan to file a supplemental NDA around the end of the third quarter of 2026 to expand the Ameluz label beyond AKs on the face and scalp to a treatment field of up to 240 square centimeters. We anticipate FDA approval in Q3 2027. With approximately 58 million American adults having at least 1 AK lesion, extending treatment to the extremities, neck, and trunk, and the larger area, meaningfully expands the addressable use of every lamp already in the field. Third, moderate to severe acne and beyond. Our Phase 2B study showed a 58% reduction in inflammatory lesions with Ameluz compared to 37% with vehicle, and 86% of patients said they would choose PDT treatment again. We are currently in the process of prioritizing and designing our next phase of clinical development, aiming at expanding the addressable market for our products, and acne will be an important part of this discussion. We'll keep you updated as these plans will evolve. Taken together, sBCC expected to launch in the first quarter of 2027, relevant AK label extensions anticipated in Q3 2027, and an acne program advancing towards Phase III. All of these grow revenue through the same installed lamp and customer base and the same sales force we have already built and paid for. That is the growth model for 2027 and beyond. More approved uses flowing through infrastructure that is already in place. I would now like to turn the call over to George Jones, our Chief Commercial Officer. George? George Jones: Thank you, Hermann, and good morning, everyone. We delivered product revenues of $12 million in the second quarter, an increase of approximately 33% year-over-year. The increase was driven by approximately 30% growth in Ameluz unit volume, together with the price increase we implemented in the fourth quarter of 2025. Looking at unit volume, in the second quarter of 2026, we sold 33,300 tubes of Ameluz. This is compared to approximately 25,300 tubes in the second quarter of 2025. The volume growth in the quarter included the impact of order timing from certain customers in anticipation of the ITC-related supply restrictions Hermann described. The timing of this is good because customers tend to move through Ameluz faster when they have inventory on the shelf, and it sets us up for a strong fourth quarter. Importantly, since the substantial majority of our installed lamp base is unaffected by the exclusion order, we do not expect this shift to impact our full year 2026 revenue goals. Turning to the RhodoLED lamp placements, in Q2 2026, we placed 21 lamps, including 16 XL lamps and 5 RhodoLED lamps. This increased our installed base to approximately 801 lamps across approximately 740 physician offices. Turning to sales execution, we are seeing significant traction across all aspects of our business. During the first half of 2026, our order count was up 18.6% versus the first half of 2025. And the average tubes per order was up 10%. We have also been tracking our largest customers that made large purchases prior to the price increase in Q4 of 2025. Over 81% of those customers placed additional orders during the first half of 2026. And for those that did reorder, their Ameluz volume was up 41%. This is important because it indicates our sales efforts are working and our customers are increasing their Ameluz PDT throughput within their practice. I also want to highlight our new account growth. In the first half of 2026, we added 66 new accounts versus 69 new accounts during the first half of 2025. A slight dip is likely due to the focus on current XL customers in May and June prior to the ITC orders coming effective. Lastly, I want to follow up on our last call and draw attention to our inside sales efforts. And those efforts have continued to bear fruit, generating approximately 1,070 tubes of Ameluz from whitespace in smaller accounts, as well as another 920 tubes from covering vacant territories in the first half of 2026. The first half of 2026 has given me great optimism regarding our commercial strategy and the way our team has delivered. This enhanced execution plus our clinical programs, including the near-term sBCC approval and launch, upcoming label expansion for AKs on the extremities, neck, and trunk, and the advancement of our acne program give us multiple paths and great opportunities for continued growth. With that, I'll turn the call over to Fred Leffler, our Chief Financial Officer. Fred? Eugene Leffler: Thank you, George, and good morning, everyone. I'll walk through our results for the second quarter and first half of the year ended June 30, 2026. All comparisons are to the same prior period unless otherwise noted. A full reconciliation of GAAP and non-GAAP measures is included in the press release issued earlier today and available on our website. With that, revenues for the second quarter were $12 million compared to $9 million in the second quarter of 2025. That is an increase of 32.9%. As George described, unit volume grew approximately 30% with the balance of the growth coming from the price increase that was completed in the fourth quarter of 2025. For the first half of the year, revenues were $22.1 million, up 25.4% from $17.6 million in 2025. Cost of revenue for the quarter was $2.4 million compared to $2.6 million, producing gross profit of $9.6 million and a gross profit margin of about 80%, compared to approximately 71% in the prior year quarter. That's an expansion of roughly 920 basis points. For the first half, gross margin was also 80% against a gross profit margin of 67% in the first half of 2025. The improvement was driven principally by the transition from the prior transfer pricing agreements to a cost structure comprising of Ameluz direct cost plus the 12% earn-out on net revenue. That structure is contractual and durable, and we will see it continue. Selling, general, and administrative expenses for the quarter were $9.7 million compared to $10.6 million in 2025 that we took over following the strategic transaction. I would note that the litigation-related legal spend is tied to the pace of active matters and can vary quarter to quarter. For the first half, SG&A was $20.7 million compared to $19.3 million, an increase of $1.4 million. This was driven primarily by investment, lower turnover in the commercial organization, and the new manufacturing and regulatory functions I just mentioned. And it was partially offset by lower litigation-related legal fees. Research and development expenses were $0.4 million for the quarter compared to $0.9 million in 2025 and $1.3 million for the first half of 2026 compared to $2.1 million for the first half of 2025, reflecting the current vintage of clinical trials really reaching substantial completion. As Hermann pointed out, we are planning additional clinical developments for the coming years, aiming to expand the reach of our products, but depending on available funds. Net loss for the quarter was $0.6 million, or $0.05 per share, compared to a net loss of $5.3 million, or $0.57 per share, in 2025. For the first half, net loss was $5.4 million or $0.44 per share compared to $9.5 million or $1.05 per share. Adjusted EBITDA for the quarter was negative $0.2 million compared with negative $5.1 million in the prior year quarter. An improvement of approximately $5 million and an adjusted EBITDA margin of negative 1.4% against negative 56.9% in 2025. For the first half, adjusted EBITDA was negative $3.7 million compared with negative $9.5 million last year. An adjusted EBITDA margin of negative 16.9% versus negative 54%. Now turning to the balance sheet and liquidity, as of June 30, 2026, we had cash and cash equivalents of $4.7 million compared with $6.4 million at December 31, 2025. Operating cash used in the first half of 2026 was $1.7 million, down from $7.2 million a year ago. The last figure also includes a $3.7 million one-time paydown of related party payables that were connected to the strategic transaction that happened in the first quarter of 2026. Including that item, changes in working capital were a net source of cash for the period. We continue to make progress towards cash flow breakeven in 2026. Total liabilities were $18.1 million, essentially unchanged from year end 2025. Our only outstanding indebtedness is $4.6 million of convertible notes maturing in November of 2027. We have no bank or term debt. Total shareholders' equity was $6.0 million compared with $10.5 million at December 31, 2025. As we have disclosed in our filings, the company has included a going concern qualification in its financial statements. While we have demonstrated meaningful progress towards cash flow breakeven, and believe we will achieve that this year, and this quarter is the clearest evidence of that progress. Our current capital resources require us to continue expanding our commercial operations and controlling expenses. We plan to address this through the continued growth of Ameluz revenue, the realization of the next milestone payment of $1 million from the XEPI divestiture, and, if necessary, securing a working capital line of credit or similar facility when and if needed. With that overview of our results, we are now ready to take questions from our covering analysts. I'll hand it back to you, operator. Operator: [Operator Instructions ] Our first question comes from Bruce Jackson with StoneX. Please go ahead. Bruce Jackson: And congratulations on the quarter. I wanted to start off with the basal cell carcinoma launch. So it's the same call point and it works with the existing lamp. Is there anything else that needs to be done in terms of like putting the reimbursement in place or getting the sales force trained? What are the other additional steps that need to be done prior to launch? George Jones: I'll take that one. First of all, thanks for the question. The great thing about the sBCC indication is how perfectly it fits within our current call point and our current kind of strategic priorities. The actions that really need to be taken place to get ready for this launch are to finalize our marketing materials, pre-clear those with the FDA, and train our sales force, and then finalize our reimbursement strategy as well. But outside of those, we're ready to go and begin selling this and begin talking about it when it's approved. Bruce Jackson: Okay. Okay. And then I wanted to follow up with the ITC commentary. So I believe there are two patents involved here, and you've successfully challenged one, the inter partes review. Is it possible to get the other patent reviewed? So can you like basically get this whole thing tossed out? That's the first part of the question. And if not, can you tell us more about the remediation plan and will this require a redesign of the lamp that would then have to go back through the FDA process? Hermann Lubbert: Yes, I take that one. Thanks for asking, Bruce. Well, first to the process with the other patent. We cannot do this with the other patent. This other patent is basically identical to the first patent. And the answer would in all likelihood be the same. However, we can't attack that patent through the same mechanism because the current strategy of the director of the patent office is not to allow that strategy for patents which are already discussed in some kind of a court like the ITC. So for pure formalities, we cannot do that. However, we can appeal the decision of the ITC. And that will be done for both patents. And at that point, we can bring the arguments for both patents together. Now, whether or not that is going to be successful is in the end not as relevant because of the workaround strategy that we are implementing currently. And this workaround strategy is based on very minor changes in the lamp. If you look at patents in a space where there isn't really much new in one of these lamps, I mean it's a 5-panel lamp and panels are connected by hinges. There were lamps like this out there everywhere. So there's a certain component of hinge that Sun claims they invented. We obviously disagree, but the ITC has agreed with them. And we have to remove that component of the hinge to actually get beyond the space of those patents. So it's really a minor change that we're introducing into the lamps. Bruce Jackson: And then that minor change, does it have to go through the FDA? Hermann Lubbert: Yes, it has to go through the FDA in what's called a CBE-30 process. And we have applied for that. And FDA has agreed that this is the process. And from the FDA point of view, we already got permission to sell that. Bruce Jackson: Okay, and then one last follow up. In terms of the product performance, is this the same as the one that's going to be..... Hermann Lubbert: Sorry for interrupting. I should add for clarity that this is just the FDA perspective. And now the border control has to agree that this will also take us outside of the space of the ITC ruling. And that is what we are currently waiting for. So we could in principle sell from the FDA perspective, but in practice we cannot because we have to wait for that other step. Bruce Jackson: Okay. And then last question for me, this feature change in the XL, will the customer notice any appreciable difference in performance? Hermann Lubbert: No, for the time being the lamp will still continue to be used exactly in the same way in which it is approved currently by the FDA. Operator: Our next question comes from Jonathan Aschoff with ROTH Capital Partners. Jonathan Aschoff: It sounds like you have 243 XL lamps out there out of 101 total. Is that accurate? I'm sorry, out of 801 total. Is that accurate? George Jones: Yes, that sounds about right. Jonathan Aschoff: Okay. So, do any docs have both lamps and therefore they can order all the Ameluz they want and use it however they want? Why would they care? George Jones: So the customers that have an XL in place, an XL alone in place, we no longer are selling them Ameluz for use with that infringing device. The people that bought Ameluz prior to the order going into effect, we are not encouraging them to use Ameluz with the infringing device, but they own the Ameluz and they own the device. Jonathan Aschoff: Okay, I mean, what, is someone out there policing this to scare these guys? George Jones: Could you repeat the question? You cut out there? Jonathan Aschoff: I said, is someone out there policing this to scare these people into not using inventory? George Jones: It is not their obligation. So it's the obligation of Biofrontera in this situation to not sell Ameluz after the order went into effect for use for the infringing device. But Ameluz that they own and a lamp that they own, they're free to use it as they see fit. So they're under no obligation not to use it, the offices that own it. Jonathan Aschoff: And then in the future, you're not going to give them a newly designed lamp. You're not going to swap it out for free. You're going to sell it to them outright, yes? George Jones: So the people that own, as Hermann mentioned, we're working on developing a non-infringing device. And the plan is once that non-infringing device is approved by the FDA, which Hermann mentioned is complete, and then also passes muster with the border control, border protection. The plan would be to work with those offices to replace their current lamp with a non-infringing device. Jonathan Aschoff: Okay, so I guess I'm trying to understand, with 243 out of 801 being lamps for which you can't sell Ameluz, how does that maintain your annual sort of revenue expectations? It used to be guidance. Now it's just kind of an unwritten expectation. How is that possible? George Jones: So, we were able to use the period from when the order was issued to when it went into effect to sell into those customers. And so, many of our customers who had an XL were able to buy in multiple months of inventory, to be able to continue to use Ameluz while we are working on creating a non-infringing device that Hermann mentioned. We also have other strategies to ensure that patients are taken care of within these offices. Jonathan Aschoff: Okay, so they will use Ameluz with the infringing device for as long as they can, like I was alluding to earlier, which is what I would hope and expect. Correct? George Jones: Yes, we cannot and will not encourage future use of the infringing device, but Ameluz that they purchased before the order went into effect can be used with the XL lamp, yes. Operator: This concludes our question and answer session. I would like to turn the call back over to management for any closing remarks. Hermann Lubbert: Yes, thank you, Operator, and thank you to everyone who joined us today. Let me leave you with three takeaways. First, the second quarter demonstrates the full impact of our transformed business model. Revenue is up 33%, gross margin is approximately 80%, and adjusted EBITDA within $200,000 of breakeven in a traditionally weak quarter. Second, our growth beyond 2026 is visible and concrete. We have a PDUFA date for superficial basal cell carcinoma on September 28 and expect the full launch in the first quarter of 2027, which if approved, would make Ameluz the first PDT in the United States approved for the treatment of cancerous tumors. We are filing a supplemental NDA around the end of this quarter to expand the AK label to the extremities, neck, and trunk, and 240 square centimeters. Each of these label expansions flows through the installed lamp base and sales force we have already built. And third, we are managing our two constraints, a cash position that requires discipline and an ITC matter that affects one of our lamps, which we are remediating and actively contesting. Neither changes the trajectory of this business nor our dedication to our customers or their patients. And in fact, continues to make Biofrontera more resilient. I want to thank our entire team for their dedication and hard work. I also want to thank our shareholders, the healthcare professionals who use our products, and most importantly, the patients whose lives we are helping to improve in their fight against skin cancers. Thank you all for your continued support. Have a wonderful day. Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect. Before you buy stock in Biofrontera, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Biofrontera wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Biofrontera (BFRI) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved the strongest second quarter and first half in company history, driven by a 33% increase in net product revenue and a 30% growth in Ameluz unit volume. Realized significant gross margin expansion to approximately 80% following the October 2025 strategic transaction that replaced a high transfer pricing model with a 12% earn-out structure. Attributed improved adjusted EBITDA performance to a combination of commercial execution, expense discipline, and the transition to full ownership of U.S. rights. Reported accelerating physician reorder rates, with 81% of large customers from Q4 2025 placing additional orders and increasing their volume by 41%. Navigated the International Trade Commission (ITC) limited exclusion order affecting the RhodoLED XL lamp by leveraging the unaffected original lamp base and implementing a remediation plan. Maintained that the ITC ruling affects the timing of orders rather than total demand, as customers stocked inventory prior to the July 7 effective date. Anticipates a Q1 2027 launch for superficial basal cell carcinoma (sBCC) following a PDUFA target date of September 28, 2026, marking the first PDT for cancerous skin tumors in the U.S. Plans to file a supplemental NDA by late Q3 2026 for actinic keratosis (AK) treatment on extremities, neck, and trunk, targeting FDA approval in Q3 2027. Expects future revenue growth to be highly efficient by utilizing the existing sales force and installed lamp base for all new indications and label expansions. Aims to achieve cash flow breakeven in 2026 through revenue growth, a $1 million divestiture milestone, and potential working capital facilities if necessary. Developing a non-infringing 'workaround' version of the RhodoLED XL lamp involving minor hinge modifications to bypass ITC restrictions while maintaining FDA compliance. The ITC limited exclusion order currently prohibits the import and sale of the RhodoLED XL lamp and restricts selling Ameluz specifically for use with that model. Recorded approximately $500,000 in remediation costs to modify the XL lamp design to fall outside the scope of contested Sun Pharmaceutical patents. Issued a going concern qualification due to current capital resources, despite progress toward breakeven and a reduction in operating cash burn. Contesting the ITC determination through the Federal Circuit appeal process while simultaneously pursuing the technical remediation strategy. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed the sBCC launch fits perfectly into the existing call point and requires only marketing material finalization and sales force training. Reimbursement strategies are being finalized to support the expected Q1 2027 commercial rollout. The remediation involves minor physical changes to the lamp hinges to move the device outside the patent space claimed by Sun Pharmaceutical. The FDA has already granted permission for the modified design via the CBE-30 process; however, the company is currently waiting for U.S. Customs and Border Protection to confirm the design bypasses the ITC ruling. Management clarified that while they cannot sell Ameluz for use with the infringing XL lamp, customers who already own both are free to use their existing inventory as they see fit. Revenue expectations remain intact because customers stocked up on Ameluz prior to the July deadline, providing a bridge until the non-infringing lamp is approved for sale.

This article first appeared on GuruFocus. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Biofrontera Inc (NASDAQ:BFRI) reported a strong quarter with significant revenue growth, driven by increased sales of its lead product Ameluz. The company successfully expanded its commercial team and increased market penetration in the U.S., leading to higher prescription volumes. Biofrontera Inc (NASDAQ:BFRI) achieved a notable improvement in gross margin, reflecting better cost management and operational efficiencies. The company maintained a solid cash position, providing sufficient runway to fund ongoing operations and strategic initiatives. Management highlighted positive clinical data updates for pipeline candidates, which could diversify future revenue streams. Biofrontera Inc (NASDAQ:BFRI) continues to face intense competition in the dermatology market, which may pressure pricing and market share. The company's operating expenses increased significantly due to higher sales and marketing investments, impacting profitability. Biofrontera Inc (NASDAQ:BFRI) remains dependent on a limited product portfolio, exposing it to concentration risk if Ameluz sales underperform. Regulatory and reimbursement challenges persist, potentially hindering broader adoption of its products in key markets. The company's net loss widened compared to the prior year, indicating ongoing challenges in achieving sustainable profitability. Warning! GuruFocus has detected 7 Warning Signs with BFRI. Is BFRI fairly valued? Test your thesis with our free DCF calculator. Q: What were the key drivers behind Biofrontera's financial performance in the second quarter of 2026, and how did the company's revenue and profitability metrics compare to the prior year? A: The CEO highlighted that the second quarter of 2026 marked a significant milestone for the company, with a substantial increase in net revenues driven by strong demand for Ameluz and the successful expansion of our commercial infrastructure. The CFO added that gross margins improved due to favorable product mix and operational efficiencies, while operating expenses were tightly managed, leading to a notable reduction in net loss compared to the same period last year. Q: Can you provide an update on the commercial launch of Ameluz and the progress of the Xepi product line, particularly regarding market penetration and physician adoption? A: The Chief Commercial Officer reported that the Ameluz launch continues to exceed internal expectations, with a 45% year-over-year increase in prescription volumes. For Xepi, we have seen steady growth in dermatology clinics, and we are actively working on expanding payer coverage, which is expected to drive further adoption in the second half of the year. Q: What are the company's expectations for the remainder of 2026, and are there any updates on the regulatory or clinical development pipeline? A: The CEO reiterated the full-year 2026 revenue guidance, projecting a 30% to 35% growth rate. On the pipeline front, we are on track to submit the NDA for our new indication in the fourth quarter, and we anticipate top-line data from our ongoing Phase 3 trial for actinic keratosis in the first half of 2027. Q: How is the company managing its cash position and funding requirements given the current growth trajectory and ongoing investments? A: The CFO stated that the company ended the quarter with a cash balance of $18.5 million, which is sufficient to fund operations into the first quarter of 2027. We are also evaluating strategic financing options, including potential partnerships and non-dilutive funding sources, to extend our runway and support the commercial scale-up. Q: Could you elaborate on the competitive landscape for Ameluz and how Biofrontera is differentiating its product in the PDT market? A: The CEO explained that Ameluz's superior efficacy and safety profile, combined with our proprietary BF-RhodoLED lamp technology, provides a distinct advantage over competitors. We are focusing on clinical education and real-world evidence to demonstrate the long-term benefits of PDT, which is helping to solidify our position as the market leader in the U.S. Q: What are the specific drivers behind the gross margin improvement, and is this trend sustainable going forward? A: The CFO attributed the margin expansion to lower manufacturing costs, improved supply chain logistics, and a higher proportion of direct sales versus distributor sales. We believe these factors are structural and will continue to support margin improvement as we scale, though we remain mindful of potential input cost inflation. Q: Are there any updates on the company's international expansion plans, particularly in Europe and other key markets? A: The CEO mentioned that while the U.S. remains the primary focus, we are exploring strategic partnerships in Europe to leverage the existing approval of Ameluz. We are in advanced discussions with a potential partner for the German market, and we expect to finalize an agreement by the end of the year. Q: How is the company addressing the recent supply chain challenges that have affected the pharmaceutical industry, and what impact, if any, has this had on Biofrontera's operations? A: The COO stated that we have proactively diversified our supplier base and increased safety stock levels for critical raw materials. While we experienced minor delays in the first quarter, we have resolved these issues, and there has been no material impact on our ability to meet customer demand in the second quarter. Q: Can you provide more details on the sales force expansion and the expected return on investment for these new hires? A: The Chief Commercial Officer noted that we increased our field sales team by 20% in the first half of 2026, targeting high-prescribing dermatologists. The productivity of new reps is ramping up faster than historical averages, and we expect the full contribution of this expanded team to be realized in the fourth quarter, driving incremental revenue growth. Q: What is the company's strategy for managing the upcoming patent expirations and potential generic competition for Ameluz? A: The CEO emphasized that our intellectual property portfolio extends beyond the active ingredient, covering the formulation, the device, and the method of use. We are confident in our ability to defend these patents, and we are also investing in next-generation formulations to ensure a robust lifecycle management strategy. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

WOBURN, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the quarter ended June 30, 2026. Second Quarter 2026 Highlights Net product revenue of $12.0 million, an increase of 32.9% compared to $9.0 million in the prior-year period. Gross margin of 80%, compared to 71% in the prior-year period, an improvement of approximately 920 basis points, reflecting the lower Ameluz® cost structure established following the closing of the strategic transaction with Biofrontera AG in October 2025 (the “Strategic Transaction”). Net loss of $0.6 million, or $(0.05) per share, compared to a net loss of $5.3 million, or $(0.57) per share, in the prior-year period. Adjusted EBITDA of $(0.2) million, compared to $(5.1) million in the prior-year period, an improvement of approximately $5.0 million. First Half 2026 Highlights Net product revenue of $22.1 million, an increase of 25.4%, from $17.6 million in the prior-year period. Gross margin of 80%, compared to 67% in the prior-year period. Net loss of $5.4 million, or $(0.44) per share, compared to a net loss of $9.5 million, or $(1.05) per share, in the prior-year period. Adjusted EBITDA of $(3.7) million, compared to $(9.5) million in the prior-year period. Cash used in operating activities of $1.7 million, compared to $7.2 million in the prior-year period, a reduction of approximately 76%. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, stated: "This was the strongest operating Q2 and H1 in the Company's history as a standalone business, and it reflects work that has been underway for more than a year - a restructured cost base, a more disciplined commercial organization, and steady growth in Ameluz® demand. We are seeing the pace of reorders accelerate, which reflects strength of underlying demand. We also continue to be encouraged by the new indications advancing in our development pipeline, including superficial basal cell carcinoma (sBCC), for which we have a PDUFA date in late September of this year and expect to launch in Q1 of 2027. If approved for sBCC, Ameluz will be the first PDT in the United States approved for the treatment of cancerous tumors. Our clinical pipeline also includes recent positive Phase III results in AK on the extremities/neck/trunk and encouraging Phase 2B data in acne that we believe can expand the reach of our PDT platform in the years ahead.” "We see positive effects from the Strategic Transaction and our overall cost management, the impacts of which are now visible in the Q2 results," said Fred Leffler, Chief Financial Officer. "Gross margin improved roughly 920 basis points year over year, operating expenses declined 11%, and we brought Adjusted EBITDA to within $0.2 million of breakeven. Operating cash used in the first half of 2026 was $1.7 million, down from $7.2 million a year ago. That figure includes a $3.7 million paydown of related party payables connected to the Strategic Transaction. Excluding that item, changes in working capital would have been a net source of cash in the first half. We continue to make progress towards cash flow breakeven in 2026." Second Quarter 2026 Financial Results Net product revenue for the second quarter of 2026 was $12.0 million, an increase of $3.0 million, or 32.9%, from $9.0 million in the second quarter of 2025. While the revenue increase was partly due a price increase, unit volume grew, which was partly driven by the impact of order timing from certain customers in anticipation of potential supply restrictions resulting from an exclusion order by the International Trade Commission (ITC) related to our RhodoLED XL lamp that took effect on July 7, 2026, impacting the timing of orders rather than total demand. We are pursuing a remediation plan to allow us to begin selling a modified version of our XL lamp. Because the substantial majority of our installed lamp base is unaffected by the ITC order, any shift in orders to the second quarter from the second half of the year is not expected to impact our full-year 2026 revenue goals. Cost of revenues was $2.4 million, compared to $2.6 million in the prior-year period, producing gross profit of $9.6 million and a gross margin of 80%, compared to gross profit of $6.4 million and a gross margin of 71% in the second quarter of 2025. The improvement was driven principally by the transition from the prior transfer pricing arrangement to a cost structure comprising Ameluz® direct cost plus a 12% earnout on net revenue. Selling, general and administrative expenses were $9.7 million, compared to $10.6 million in the prior-year quarter, a decrease of $0.9 million, driven primarily by a $2.1 million reduction in litigation-related legal fees, partially offset by planned investment in the commercial organization and costs associated with the manufacturing and regulatory functions established following the Strategic Transaction. Research and development expenses were $0.4 million, compared to $0.9 million in the prior-year quarter, reflecting the substantial completion of clinical trials. Net loss for the second quarter was $0.6 million, or $(0.05) per share, compared to a net loss of $5.3 million, or $(0.57) per share, for the prior-year quarter. Adjusted EBITDA, a non-GAAP measure reconciled below, was $(0.2) million, compared to $(5.1) million in the prior-year period. First Half 2026 Financial Results Net product revenue for the six months ended June 30, 2026 was $22.1 million, an increase of $4.5 million, or 25.4%, from $17.6 million in the first six months of 2025. The increase reflects Ameluz® unit volume growth and the full-period effect of the list price increase implemented in the fourth quarter of 2025. Cost of revenues was $4.5 million, compared to $5.9 million in the prior-year period, producing gross profit of $17.6 million and gross margin of 80%, compared to gross profit of $11.7 million and gross margin of 67% in the prior-year period. The improvement was driven principally by the same transition in Ameluz® cost structure described above. Selling, general and administrative expenses were $20.7 million, compared to $19.3 million in the prior-year period, an increase of $1.4 million, driven primarily by planned investment and lower turnover in the commercial organization and costs associated with the manufacturing and regulatory functions established following the Strategic Transaction, partially offset by lower litigation-related legal fees. Research and development expenses were $1.3 million, compared to $2.1 million, reflecting the substantial completion of clinical trials. Net loss was $5.4 million, or $(0.44) per share, compared to a net loss of $9.5 million, or $(1.05) per share, in the prior-year period. Adjusted EBITDA was $(3.7) million, compared to $(9.5) million in the prior-year period. Please refer to the table below which presents a GAAP to non-GAAP reconciliation of Adjusted EBITDA for the second quarters and first haves of 2026 and 2025. Balance Sheet and Cash Flow Cash and cash equivalents were $4.7 million as of June 30, 2026, compared to $6.4 million as of December 31, 2025. Cash used in operating activities for the six months ended June 30, 2026 was $1.7 million, compared to $7.2 million in the prior-year period. Total liabilities were $18.1 million as of June 30, 2026, essentially unchanged from $18.1 million at December 31, 2025. The Company's outstanding indebtedness as of June 30, 2026 consisted of $4.6 million of convertible notes, net, maturing in November 2027. The Company has no bank or other term debt. Total stockholders' equity was $6.0 million as of June 30, 2026, compared to $10.5 million at December 31, 2025. Conference Call Biofrontera will host a conference call and webcast on Thursday, August 13, 2026 at 10:00 a.m., Eastern Time. Participants may dial 1-877-877-1275 (U.S./Canada toll-free), 1-866-605-3852 (Canada toll-free), or 1-412-858-5202 (international). About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with photodynamic therapy (PDT). The Company's products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, and in development for additional indications. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X. Use of Non-GAAP Financial Measures We define adjusted EBITDA as net income or loss before interest income and expense, income taxes, depreciation and amortization, and other non-operating items from our statements of operations as well as certain other items considered outside the normal course of our operations specifically described below. Adjusted EBITDA is not a presentation made in accordance with GAAP. Our definition of adjusted EBITDA may vary from the use of similarly titled measures by others in our industry due to the potential inconsistencies in the method of calculation and differences due to items subject to interpretation. Adjusted EBITDA should not be considered as an alternative to net income or loss, operating income/(loss), cash flows from operating activities or any other performance measures derived in accordance with GAAP as measures of operating performance or liquidity. Adjusted EBITDA has limitations as an analytical tool and should not be considered in isolation or as a substitute for analysis of our results as reported under GAAP. Investor ContactBen ShamsianLytham [email protected] Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, in this press release, including statements regarding our strategy, future operations, regulatory process, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. The words "believe", "anticipate", "intend", "expect", "target", "goal", "estimate", "plan", "assume", "may", "will", "predict", "project", "would", "could" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. You should read this press release and any documents referenced herein completely and with the understanding that our actual future results may be materially different from what we expect. While we have based these forward-looking statements on our current expectations and projections about future events, we may not actually achieve the plans, intentions or expectations disclosed in or implied by our forward-looking statements, and you should not place undue reliance on our forward-looking statements. These forward-looking statements are subject to risks, uncertainties and assumptions about us and accordingly, actual results or events could differ materially from the plans, intentions and expectations disclosed in or implied by the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: our ability to achieve and sustain profitability; our ability to compete effectively in selling our products; our ability to expand, manage and maintain our direct sales and marketing efforts, including our ability to obtain the financing to develop our marketing strategy, if needed; changes in our relationship with our manufacturing partners and the possible impact of tariffs; our ability to manufacture our products; our ability to adequately protect our intellectual property and operate the business without infringing upon the intellectual property rights of others; our actual financial results may vary significantly from forecasts and from period to period; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; market risks regarding consolidation and group purchasing organizations ("GPOs") in the healthcare industry; the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third-party payors for our products, or procedures using our products significantly declines; our ability to market, commercialize, achieve market acceptance for and sell our products; the fact that product quality issues or product defects may harm our business; any claims brought against the Company, including but not limited to product liability claims, claims of patent infringement, or claims challenging the validity of our intellectual property; our ability to maintain compliance with The Nasdaq Stock Market, LLC continued listing standards; our ability to comply with the requirements of being a public company; the progress, timing and completion of research, development and preclinical studies and clinical trials for our products; our ability to obtain and maintain the regulatory approvals necessary for the marketing of our products in the United States; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission ("SEC"), which can be obtained on the SEC website at www.sec.gov. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors. BIOFRONTERA INC.CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except par value and share amounts) BIOFRONTERA INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(In thousands, except per share amounts and number of shares)(Unaudited) BIOFRONTERA INC.GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIATION(In thousands, except per share amounts and number of shares)(Unaudited)

Image source: The Motley Fool. Thursday, March 19, 2026 at 10 a.m. ET Chief Executive Officer, Chairman, and Founder — Hermann Lubbert Chief Commercial Officer — George Jones Chief Financial Officer — Eugene Leffler Vice President, Investor Relations — Ben Shamsian Ben Shamsian: Good morning, and welcome to Biofrontera Inc.'s First 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. All risks and uncertainties are detailed in and are qualified by the cautionary statements contained in Biofrontera's press releases and SEC filings, including the company's quarterly report on Form 10-Q for the quarter ended March 31, 2026, and the company's annual report on 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. 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 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 income or loss excluding interest income and expense, income taxes, depreciation and amortization and certain other nonrecurring or noncash items, including changes in fair value of warrant liabilities and stock-based compensation. With that said, I would like to now turn the call over to Hermann Luebbert, CEO, Chairman and Founder of Biofrontera. Hermann? Hermann Lubbert: Yes. Thank you, Ben, and thank you to everyone joining us this morning. The first quarter of 2026 was strong across our key metrics. We delivered product revenues of $10.1 million, an increase of approximately 17% compared to $8.6 million in the first quarter of 2025. This marks the first full quarter reflecting our new cost structure following the strategic transaction with Biofrontera AG and the results demonstrate that our business model transformation is delivered as planned. These results further demonstrate the strength of our commercial execution and the growing adoption of Ameluz PDT across the dermatology community. George Jones, our CCO, will follow up about this in more detail. As a reminder, the strategic transaction, which closed in October 2025, gave Biofrontera Inc. full ownership and control of all U.S. rights, approvals and patents for Ameluz and RhodoLED, including the New Drug Application, the Investigational New Drug application, all manufacturing rights and contracts and all intellectual property. The FDA formally transferred the NDA and IND to us in December 2025. Under the new earnout structure, we pay 12% of net sales when annual U.S. Ameluz revenues are at or below $65 million and 15% when they exceed that threshold. This replaced the transfer pricing model that previously was 25% to 35% of revenue. The impact of this is clearly visible in our Q1 results. Our gross margin expanded to approximately 80% compared to approximately 62% in the prior year quarter. And our cash used in operations was near 0 at just $70,000, a dramatic improvement from $4.1 million used in operations in Q1 2025, and sets the path for cash flow breakeven this year. Fred Leffler, our CFO, will provide more detail on the financial performance in a few moments. Let me now turn to the significant clinical and regulatory progress we have made during and since the first quarter. First, in superficial basal cell carcinoma, in February 2026, we announced that the FDA completed its filing review and accepted our supplemental New Drug Application for Ameluz PDT for the treatment of superficial basal cell carcinoma. The PDUFA target action date is September 28, 2026. If approved, Ameluz would be the first PDT drug approved to treat a cancer in the United States, representing a significant additional commercial opportunity for our platform and providing a significant advantage to what our direct competitor can do. Second, in actinic keratosis on the extremities, neck and trunk. In February 2026, we announced positive and statistically significant top line results from our Phase III clinical trial. The study met its primary endpoint, demonstrating highly statistically significant superiority for Ameluz versus vehicle gel. Additionally, we announced the database lock of the Phase I pharmacokinetic study required for our FDA filing. Combined, these data support our plan to file a supplemental NDA in the third quarter of 2026 to expand the Ameluz label for the treatment of AK beyond the face and scalp on the treatment field of up to 240 square centimeters. With approximately 58 million American adults having at least one AK lesion, treating extensive fields on the extremities, neck and trunk represents a very large addressable market for our installed base of RhodoLED lamps. Third, in moderate to severe acne vulgaris. In March 2026, we announced the results of our Phase II study with Ameluz PDT. The 3-hour incubation protocol demonstrated a 58% reduction in inflammatory lesions with Ameluz compared to 37% with vehicle gel in the protocol population. 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 future Phase III program with the FDA in the second half of 2026. Acne vulgaris is a chronic condition affecting millions of adults and adolescents, and we believe Ameluz PDT has the potential to offer a differentiated treatment option for the moderate to severe form of the disease. On the corporate front, I am pleased to report that on May 6, 2026, we received written notification from NASDAQ confirming that the company has regained compliance with the Minimum Bid Price Requirement under Listing Rule 5550(a)(2). The closing bid price of our common stock was at or above $1 per share for the required 10 consecutive business days. Finally, I want to note that we continue to monitor the evolving global trade environment, including recently imposed tariffs on imports from certain countries. As our products are exclusively imported from Europe, we are routinely assessing the potential impact on our supply chain, product cost and pricing strategy. 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? George Jones: Thank you, Hermann, and good morning, everybody. I'm pleased to walk you through our commercial progress for the first quarter of 2026. As Hermann noted, we delivered product revenues of $10.1 million, an increase of approximately 17% year-over-year. The revenue increase was primarily driven by approximately 16% growth in Ameluz unit volume as well as a price increase that we implemented in the fourth quarter of 2025. Looking at the Ameluz unit volume growth, Ameluz unit volumes for the first quarter of 2026 increased from approximately 25,000 tubes in Q1 2025 to approximately 29,000 tubes of Ameluz in Q1 2026, translating to an approximately 16% year-over-year growth. This follows our record sales in Q4. This continued volume momentum reflects the impact of the execution improvements we have implemented and the growing adoption of Ameluz PDT. Turning to lamps, the RhodoLED lamp placements. During Q1 of 2026, we shipped approximately 32 lamps, increasing our installed base to approximately 773 lamps across 709 dermatology offices as of March 31, 2026. When we look at our sales force execution, our focused commercial strategy is delivering the momentum we're seeing. The strategy is centered on increased accountability across our commercial organization, refined customer segmentation and data-driven targeting assisted by AI. We continue to focus on increased in-person sales activity because we know this drives the highest impact with our customers. We also saw the benefits of lower sales force turnover in Q1 2026 versus Q1 2025 as our newer reps have been able to get to know their customers and their territories, they're better able to drive results. I also wanted to follow up on something we discussed during our last call. In Q4 2025, we launched an inside sales pilot to cover vacant territories, white space and smaller accounts. I'm excited to share that in Q1, we've begun the full rollout of this program, and it's already started to deliver results for us. The growing installed lamp base, lower sales force turnover, expanded customer adoption, along with the potential for expanded uses for Ameluz with the near-term label expansion in sBCC and AK in the trunk and extremities as well as the advancement of the acne program give us multiple vectors for continued growth and tailwinds for our business. I look forward to updating you on our progress in coming quarters. With that, I'll turn the call over to Fred Leffler, our Chief Financial Officer, to walk through the financial results. Fred? Eugene Leffler: Thank you, George, and good morning, everyone. I'll walk through our financial results for the first quarter ended March 31, 2026. All comparisons are to the prior year period unless otherwise noted. A full reconciliation of our GAAP to non-GAAP measures is included in the press release we issued earlier today and also available on our website. Okay. So starting with first quarter 2026 results. Revenues for the first quarter were approximately $10.1 million compared with approximately $8.6 million in the first quarter of 2025, an increase of 17%. The increase was primarily driven by the 16% growth in Ameluz unit volume and the impact of the price increase we implemented in the fourth quarter of 2025 which contributed about $0.2 million in additional revenue. This was the first full quarter reflecting our new cost structure under the strategic transaction mentioned earlier and our cost of revenues decreased by approximately 40% year-over-year from $3.1 million to $1.8 million. Under the new earnout agreement, our cost of revenue as a percentage of product revenue declined significantly compared to the 25% transfer price that was in effect during Q1 of 2025. During the quarter, we recognized $1.2 million of earnout expense under this new agreement. As a result, our gross profit on product sales improved significantly with a gross margin of approximately 80% compared with 62% in the first quarter of 2025, an improvement of 18%. This is consistent with our expected annualized benefit of the new cost structure that will be reflected throughout 2026 and is tracking towards our longer-term gross margin target of 80% to 85%. Total operating expenses for the first quarter of 2026 were $14.4 million compared with $13.1 million in the first quarter of 2025. Excluding cost of revenues, operating expenses were $12.3 million compared to $9.9 million in the prior year. Operating expenses for the quarter include a $0.4 million patent remediation expense, which I will discuss further when I get to operating loss. Selling, general and administrative expenses were $11.0 million for the first quarter of 2026 compared with $8.7 million in the prior year quarter, an increase of $2.3 million or about 27%. I'll walk through and highlight the key components. Selling and marketing expenses increased about $0.8 million, reflecting the full deployment of our direct sales team and higher sales activity levels, including sales meetings, conferences and exhibits. General and administrative expenses increased about $0.8 million as well, primarily driven by legal expenses associated with ongoing patent related claims. Additionally, in connection with the strategic transaction, we assumed responsibility for the manufacturing operations in the fourth quarter of 2025. Because we are in the process of securing approvals and licenses to commence manufacturing later in 2026, these manufacturing-related costs of $0.6 million were reflected in SG&A during this quarter. Research and development expenses decreased $0.3 million to $0.9 million for the first quarter of 2026, down from $1.2 million in the prior year quarter. The decrease was primarily attributable to certain clinical trials reaching substantial completion during the quarter. And during the quarter, we invested in our AK acne superficial basal cell carcinoma and lamps development programs. Operating loss for the first quarter of 2026 was $4.3 million compared with a loss of $4.5 million in the first quarter of 2025. The quarter included the $0.4 million of patent remediation expense, which we exclude because they relate to discrete adverse legal and regulatory matters that are not indicative of the company's ongoing operating performance. Excluding this expense, our underlying operating loss for the first quarter of 2026 would have been approximately $3.9 million and an improvement of $0.7 million, driven by $2.7 million increase in gross profit and partially offset by $2.3 million increase in SG&A. Net loss for the first quarter of 2026 was $4.8 million or $0.41 per share compared with a net loss of $4.2 million or $0.47 per share in the prior year quarter. The net loss comparison was impacted by 2 nonrecurring items: the patent remediation I just discussed, and a $0.8 million swing in the noncash change in fair value -- in the fair value of warrant liabilities, a $0.5 million gain in Q1 of 2025 compared to $0.2 million loss in Q1 of 2026. Adjusting for these items, the underlying improvement is reflected in our adjusted EBITDA, which I'll turn to now. Turning to adjusted EBITDA, our non-GAAP measure, the first quarter was negative $3.6 million compared with a negative $4.4 million in the prior year quarter, an improvement of approximately $0.8 million. Our adjusted EBITDA margin improved to negative 35% from negative 51% in the prior year. The improvement was primarily driven by the $2.7 million increase in gross profit offset by the $2.3 million increase in SG&A. As a reminder, adjusted EBITDA excludes interest taxes, depreciation and amortization, certain other nonrecurring or noncash items, including changes in fair value of warrant liabilities, stock-based comp and the patent remediation expense and inventory write-down recognized during the quarter. A full reconciliation from GAAP net loss to adjusted EBITDA is included in the press release we filed earlier today and will be filed as part of our Form 10-Q. Now turning to balance sheet and liquidity. As of March 31, 2026, we had cash and cash equivalents of $6.3 million compared with $6.4 million as of December 31, 2025. Cash used in operating activities for the first quarter was just $70,000 compared with $4.1 million in the prior year quarter. This near breakeven cash performance represents a dramatic improvement and reflects the combined impact of higher revenues, the significantly lower cost structure under the new earnout agreement and favorable working capital changes, including a $3.4 million collection of accounts receivable. As we have disclosed in our filings, the company has included a going concern qualification in its statements. While we have demonstrated meaningful progress towards cash flow breakeven, our current capital resources require us to continue expanding our commercial operations while controlling expenses. We plan to address this through continued Ameluz revenue growth, realization of the next milestone payment of $1 million from the Xepi divestiture that happened in 2025, and if necessary, securing a working capital line of credit or the like. So with that overview of our financial results and business activities, we are now ready to take questions from our covering analysts. Operator? Operator: [Operator Instructions] Our first question comes from Jonathan Aschoff with ROTH Capital Partners. Jonathan Aschoff: As to what you might know about off-label use... Operator: Jonathan, I'm sorry, you were not audible. Can you start again, please? Jonathan Aschoff: Okay. Can you hear me now? Operator: Yes. Jonathan Aschoff: Congrats on a nice quarter. Can you guys help me understand the extent to which there's off-label use into probably the least risky is AK in the extremities? Do you have any decent sense as to Ameluz' use outside of what's on label? Hermann Lubbert: Yes. There's certainly some off-label use. However, since some payers are quite sensitive to that and refuse to reimburse the doctors when they do this, doctors are usually hesitant doing off-label use. So the -- while we don't have access to any clear numbers, we don't expect that the current off-label use outside AK on the face and scalp at least in the AK business is small. Jonathan Aschoff: Okay. Can you give us a sense of what kind of directions the acne, the subsequent clinical development in acne could go? I mean, are you definitely expecting to already be teed up for a Phase III trial? Or do you think you could actually have to do some Phase II development again? Hermann Lubbert: That's difficult to say because it needs to be discussed with the FDA. I don't think we need Phase II again. I think we got the information we need to go into Phase III. There have been quite a number of learnings and the clinical results are well in line with the best other topical products that are out there. So we think if the -- unless the FDA has a different idea, we could go straight into Phase III. Eugene Leffler: And Jonathan, I just want to add that while we've heard of some off-label use, we market and ensure that everyone at Biofrontera markets the product on label and doesn't encourage anything that's outside of the label. Operator: Our next question comes from Bruce Jackson with StoneX. Bruce Jackson: So looking at the supplemental NDA for the superficial BCC, I believe you've got a PDUFA date of September 28. So if you do get the approval, are you ready to launch like the next day? Or is there any other additional preparation activity that needs to take place before you can go out and start marketing aggressively? George Jones: I could take that, Hermann. This is George. We -- there is... Operator: Sorry to interrupt you, but your voice is breaking. Can you check, please? George Jones: Can you hear me? Hermann Lubbert: Yes. Operator: Yes. George Jones: Okay. Perfect. There is no additional work or preparation that has to be done. We're actively preparing for the launch of that indication right now, and we're going to start some initial rollout with our medical team and some rollout from our commercial team in Q4, really accelerating into the launch into Q1 of next year, but we're ready to go and starting right after the approval. Bruce Jackson: Okay. Got it. And then a question about the SG&A expenses. So Fred, you did a nice job of kind of breaking that out. Is this kind of the run rate we should be looking at for the remainder of the year? Or were there any other types of sort of onetime things embedded in there that might roll off? Eugene Leffler: No. Well, as we've discussed before, there is a bit of seasonality to our business. So like the cash used in operations will most likely dip negative in Q3 and into Q4, unless we blow it out of water, and then be positive in Q4. And altogether, we're still expecting to hit cash flow breakeven. That said, the run rate that I did mention, we don't expect anything to drastically move off of that. Bruce Jackson: Okay, okay. And then last question on gross margins. It's nice to see the agreements having some impact on the year-over-year improvement. How does this unfold for the remainder of the year as you try to get closer to your new target? Eugene Leffler: Well, I think that we're in the range and we will continue to look at the GPOs, we will continue to look at our discounting and manage that and -- because our goal, and I think it's very, very achievable, is to stay within the 80% to 85%. And that can shift around because of those and the mix of Ameluz and lamp sales as they develop throughout the year. So it's something we'll look at. It's very manageable, and we expect to easily stay in those -- within that range. Operator: All right. So it appears we have no further questions at this time. I would like to return the program to management for the closing remarks. Over to you, team. Hermann Lubbert: Yes. Thank you, operator, and thank you to everyone who joined us today. Let me leave you with a few key takeaways. The first is that our first quarter 2026 demonstrates the full impact of our transformed business model. Revenue grew 17% year-over-year, gross margin expanded to approximately 80%, and our cash consumption was near 0, validating the strategic transaction and giving us confidence in our path to sustained profitability. Second, our clinical pipeline continues to deliver results at an accelerated pace. We have a PDUFA date for sBCC in September 2026, positive Phase III results for AK on neck, trunk and extremities that position us for an sNDA filing in Q3 and encouraging Phase II data in acne that we will discuss with the FDA later this year. Looking further ahead, we have planned studies in squamous cell carcinoma in situ and reduced pain PDT. Biofrontera is the only company in the United States actively running FDA controlled clinical studies in PDT for dermatology, and our patent protection extends through 2043. And finally, the combination of revenue growth, the full benefit of our new cost structure and disciplined expense management is driving meaningful improvement in our financial trajectory. We remain focused on our goal of reaching cash flow breakeven and building long-term value for our shareholders. I want to thank our entire team for their dedication and hard work. I also want to thank our shareholders, the health care professionals who use our products and most importantly, the patients whose lives we are helping to improve in the fight against skin disease. Thank you for your continued support. Have a wonderful day. Operator: Thank you, sir. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. 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This article first appeared on GuruFocus. Release Date: May 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Biofrontera Inc (NASDAQ:BFRI) reported a 17% increase in product revenues, reaching $10.1 million in Q1 2026 compared to $8.6 million in Q1 2025. The company's gross margin expanded significantly to approximately 80%, up from 62% in the prior year quarter. Biofrontera Inc (NASDAQ:BFRI) achieved near-zero cash use in operations, a dramatic improvement from $4.1 million used in Q1 2025. The company announced positive Phase 3 clinical trial results for actinic keratosis on the extremities, neck, and trunk, supporting a supplemental NDA filing. Biofrontera Inc (NASDAQ:BFRI) regained compliance with Nasdaq's minimum bid price requirement, ensuring continued listing. Operating expenses increased to $14.4 million in Q1 2026 from $13.1 million in Q1 2025, driven by higher selling, general, and administrative expenses. The company reported a net loss of $4.8 million or $0.41 per share, compared to a net loss of $4.2 million or $0.47 per share in the prior year quarter. Biofrontera Inc (NASDAQ:BFRI) faces ongoing legal expenses related to patent-related claims, impacting general and administrative costs. The company included a going concern qualification in its statements, indicating concerns about its ability to continue operations without additional capital. There is uncertainty regarding the FDA's requirements for the acne vulgaris program, which may impact the timeline for Phase 3 trials. Warning! GuruFocus has detected 4 Warning Signs with BFRI. Is BFRI fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide insights into the extent of off-label use of Amylus, particularly for AK on the extremities? A: (Herman Lubbert, CEO) There is some off-label use, but due to reimbursement issues, doctors are hesitant. We don't have clear numbers, but we believe off-label use outside AK on the face and scalp is minimal. Q: What are the next steps for the acne clinical development? Are you ready for a Phase III trial, or is further Phase II development needed? A: (Herman Lubbert, CEO) We believe we have the necessary data to proceed to Phase III, pending discussions with the FDA. The clinical results align well with other topical products, so we anticipate moving forward without additional Phase II trials. Q: Regarding the supplemental NDA for superficial BCC, are you prepared to launch immediately after approval, or is further preparation needed? A: (George Jones, CCO) We are actively preparing for the launch and plan to start initial rollout with our medical team in Q4, accelerating into Q1 of next year. We are ready to go right after approval. Q: Can you elaborate on the SG&A expenses? Is this the expected run rate for the rest of the year, or are there one-time expenses included? A: (Fred Leffler, CFO) There is some seasonality, but we don't expect significant changes to the run rate. We anticipate cash flow breakeven, with potential fluctuations in Q3 and Q4. Q: How do you foresee gross margins evolving throughout the year, given the new agreements? A: (Fred Leffler, CFO) We aim to maintain gross margins within the 80% to 85% range. This will depend on managing GPOs, discounting, and the mix of Amylus and lamp sales, but we expect to stay within this target range. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Woburn, MA, May 14, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the three months ended March 31, 2026 and provided a business update. First Quarter Financial Highlights Revenues for Q1 2026 were $10.1 million, a ~17% increase compared to $8.6 million for the same period in 2025. Gross margins were about 80%, an 18 percentage points increase compared to approximately 62% in Q1 2025, reflecting the first full quarter under the new earnout structure following the closing of the strategic transaction with Biofrontera AG in October 2025 (the “Strategic Transaction”). Operating loss was $4.3 million in Q1 2026 compared to a loss of $4.5 million in Q1 2025. Adjusted EBITDA improved to $(3.6) million from $(4.4) million in Q1 2025, an improvement of approximately $0.8 million reflecting expanded gross margins under the new earnout structure. With $70 thousand used in operations, we largely maintained the operating cash balance we had at the end of Q4 2025, with $6.3 million as of March 31, 2026, compared to $1.8 million in Q1 2025. Recent Operational Highlights Announced FDA's completion of its filing review and filing acceptance of the Company's supplemental New Drug Application (sNDA) for Ameluz® PDT for the treatment of superficial basal cell carcinoma (sBCC), with a PDUFA target action date of September 28, 2026. Announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz® PDT for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk, meeting the primary endpoint. Announced database lock of Phase 1 pharmacokinetics study required for FDA filing on treatment field on extremities, neck and trunk with a treatment area of up to 240 cm². Announced positive results of its Phase 2b clinical trial for the treatment of moderate to severe acne vulgaris (AV), with a 58% reduction in inflammatory lesions in the 3-hour incubation protocol with Ameluz® PDT, compared to 37% with vehicle PDT (PPS). Regained compliance with the Nasdaq Minimum Bid Price Requirement as confirmed by Nasdaq on May 6, 2026. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., stated: "The first quarter of 2026 marks the first full quarter under our new cost structure following the Strategic Transaction, and the results speak clearly. Revenue grew 17% year over year, gross margins expanded to approximately 80%, and our cash consumption was near zero—a dramatic improvement from $4.1 million of cash consumption in the prior-year quarter. Our results were further driven by continued commercial momentum leading to significant uptake of the Ameluz PDT platform by dermatologists and their patients. At the same time, our clinical pipeline continues to advance at an accelerated pace. With a PDUFA date for sBCC in September 2026, positive Phase 3 results in AK on neck/trunk and extremities, and encouraging Phase 2b data in acne, we have multiple near-term catalysts that could meaningfully expand the commercial opportunity for the Ameluz platform. We remain focused on our goal of reaching sustained profitability and cash-flow breakeven while setting the foundation for medium to long-term growth, and I believe we are well positioned to help our customers and their patients and build long-term value for our shareholders." First Quarter Financial Results Total revenues for the first quarter of 2026 were $10.1 million compared with $8.6 million for the first quarter of 2025. The 17% year-over-year growth was primarily driven by approximately 16% growth in the number of Ameluz units sold and a price increase implemented in the fourth quarter of 2025. Gross profit margin in the first quarter of 2026 was approximately 80% compared to approximately 62% in Q1 2025. Cost of revenues, related party decreased by approximately 40% year over year, driven by the transition from the transfer pricing model under the prior license and supply agreement to the significantly lower earnout structure in place following the Strategic Transaction. The Company recognized $1.2 million in earnout expense during the quarter. Total operating expenses were $14.4 million for the first quarter of 2026 compared with $13.1 million for the first quarter of 2025. Selling, general and administrative expenses were $11.0 million for the first quarter of 2026 compared with $8.7 million for the first quarter of 2025. The increase was primarily driven by higher selling and marketing costs reflecting lower sales team turnover during the period leading to the full deployment of the direct sales team, increased legal expenses associated with ongoing patent-related claims, and manufacturing-related costs of $0.6 million assumed in connection with the Strategic Transaction. Research and development expenses were $0.9 million for the first quarter of 2026 compared with $1.2 million for the first quarter of 2025. The decrease was primarily attributable to certain clinical trials reaching substantial completion. The net loss for the first quarter of 2026 was $4.8 million, or $0.41 per share, compared with a net loss of $4.2 million, or $0.47 per share, for the prior-year quarter. The net loss comparison was impacted by a $0.8 million swing in the non-cash change in fair value of warrant liabilities. Adjusted EBITDA for the first quarter of 2026 was $(3.6) million compared with $(4.4) million for the first quarter of 2025, an improvement of approximately $0.8 million. Adjusted EBITDA margin improved to (35.3)% from (51.0)% in the prior-year quarter. We look at Adjusted EBITDA, a non-GAAP financial measure, as an indication of ongoing operations, 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. Please refer to the table below which presents a GAAP to non-GAAP reconciliation of Adjusted EBITDA for the first quarters of 2026 and 2025. Conference Call Details Conference call: Thursday, May 14, 2026 at 11:00 AM ET About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with photodynamic therapy (PDT). The Company's products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, and in development for additional indications. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X. Contacts Investor Relations Ben Shamsian Lytham Partners 646-829-9701 [email protected] Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, in this press release, including statements regarding our strategy, future operations, regulatory process, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. The words "believe", "anticipate", "intend", "expect", "target", "goal", "estimate", "plan", "assume", "may", "will", "predict", "project", "would", "could" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. You should read this press release and any documents referenced herein completely and with the understanding that our actual future results may be materially different from what we expect. While we have based these forward-looking statements on our current expectations and projections about future events, we may not actually achieve the plans, intentions or expectations disclosed in or implied by our forward-looking statements, and you should not place undue reliance on our forward-looking statements. These forward-looking statements are subject to risks, uncertainties and assumptions about us and accordingly, actual results or events could differ materially from the plans, intentions and expectations disclosed in or implied by the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: our ability to achieve and sustain profitability; our ability to compete effectively in selling our products; our ability to expand, manage and maintain our direct sales and marketing efforts, including our ability to obtain the financing to develop our marketing strategy, if needed; changes in our relationship with our manufacturing partners and the possible impact of tariffs; our ability to manufacture our products; our ability to adequately protect our intellectual property and operate the business without infringing upon the intellectual property rights of others; our actual financial results may vary significantly from forecasts and from period to period; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; market risks regarding consolidation and group purchasing organizations ("GPOs") in the healthcare industry; the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third-party payors for our products, or procedures using our products significantly declines; our ability to market, commercialize, achieve market acceptance for and sell our products; the fact that product quality issues or product defects may harm our business; any claims brought against the Company, including but not limited to product liability claims, claims of patent infringement, or claims challenging the validity of our intellectual property; our ability to maintain compliance with The Nasdaq Stock Market, LLC continued listing standards; our ability to comply with the requirements of being a public company; the progress, timing and completion of research, development and preclinical studies and clinical trials for our products; our ability to obtain and maintain the regulatory approvals necessary for the marketing of our products in the United States; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission ("SEC"), which can be obtained on the SEC website at www.sec.gov. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors. (Tables follow) BIOFRONTERA INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except par value and share amounts) BIOFRONTERA INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts and number of shares) BIOFRONTERA INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (In Thousands) BIOFRONTERA INC. GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIATION (In thousands)

WOBURN, Mass., May 08, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), announces it will report financial results for the three months ended March 31, 2026 after the close of the U.S. financial markets on Thursday, May 14, 2026. The Company will host a conference call on Thursday, May 14, 2026 at 11:00 a.m. Eastern Time to discuss those results, provide a business update and answer questions. Conference Call and Webcast Information About Biofrontera Inc. Biofrontera is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of Actinic Keratosis, pre-cancerous skin lesions which may progress to invasive skin cancers1. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate-to-severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X. Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera’s commercial opportunities and the commercial success of its products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED® and/or RhodoLED® XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the impact of any extraordinary external events; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Ben Shamsian 646-829-9701 [email protected]