Biofrontera (BFRI) 2026年第二季度业绩电话会议:营收增长33%,毛利率达80%
Biofrontera 2026财年第二季度产品收入同比增长32.9%至1200万美元,毛利率提升至80%,调整后EBITDA改善至负20万美元。受益于Ameluz销量增长与提价策略,公司持续推进现金流盈亏平衡目标。尽管面临ITC关于RhodoLED XL的进口限制,原版设备及现有库存使用未受影响,且公司正积极推进补救措施与新适应症FDA审批。
核心要点
- 2026财年第二季度产品收入同比增长32.9%至1200万美元,这得益于Ameluz产品销量增长约30%以及2025财年第四季度的提价。
- 毛利率从71%提升至约80%,主要归因于计价模式的改变:由此前的收入25%–35%的转让定价,转变为Ameluz直接成本外加净销售额12%的业绩提成(earn-out)。
- 调整后EBITDA从负510万美元改善至负20万美元,使Biofrontera在传统淡季接近盈亏平衡。
- ITC指令禁止Biofrontera在美国进口或销售当前的RhodoLED XL,并限制销售用于该设备的Ameluz。占已安装设备绝大多数的原版BF-RhodoLED不受影响。
- FDA将Ameluz用于浅表性基底细胞癌的PDUFA目标日期定为2026年9月28日。若获得批准,管理层预计将于2027年第一季度全面推出。
- 截至2026年6月30日,现金总额为470万美元。管理层继续以在2026年实现现金流盈亏平衡为目标,但财务报表中仍保留持续经营能力的审计警示。
核心财务业绩
| 指标 | 2026财年第二季度 | 2025财年第二季度 | 变化 / 评论 |
|---|---|---|---|
| 营收 | 1200万美元 | 900万美元 | 增长32.9% |
| Ameluz销量 | 33,300支 | 约25,300支 | 增长约30% |
| 营收成本 | 240万美元 | 260万美元 | 同比下降 |
| 毛利润 | 960万美元 | 约640万美元 | 毛利率 reached approximately 80% |
| 毛利率 | 约80% | 约71% | 提升约920个基点 |
| 销售、一般及管理费用 | 970万美元 | 1060万美元 | 同比下降 |
| 研发费用 | 40万美元 | 90万美元 | 随着当前临床试验接近实质性完成而有所下降 |
| 净亏损 | 60万美元 | 530万美元 | 每股亏损从0.57美元改善至0.05美元 |
| 调整后EBITDA | 负20万美元 | 负510万美元 | 利润率从负56.9%改善至负1.4% |
2026财年上半年,营收增长25.4%至2210万美元。毛利率从67%提高至80%,同时净亏损从950万美元(或每股1.05美元)收窄至540万美元(或每股0.44美元)。调整后EBITDA从负950万美元改善至负370万美元。
上半年经营现金消耗从上年同期的720万美元降至170万美元。截至2026年6月30日,现金及现金等价物为470万美元,总负债为1810万美元,股东权益为600万美元。公司唯一的未偿债务为2027年11月到期的460万美元可转换债券。
业务与经营业绩
Ameluz的销量增长是营收的主要驱动力。Biofrontera在第二季度售出了33,300支,但管理层表示,这一总量包含了在ITC相关限制生效前提前采购的数量。
上半年订单量同比增长18.6%,平均每笔订单的支数增长了10%。在2025财年第四季度提价前提前采购的大客户中,有超过81%在2026财年上半年再次下单。在这些客户中,Ameluz的采购量增长了41%。
Biofrontera在上半年新增了66个新客户账号,而上年同期为69个。内部销售团队从渗透率较低的小型客户处带来了约1,070支的销量,并通过覆盖空白区域额外贡献了920支。
公司在第二季度投放了21台治疗仪,其中包括16台RhodoLED XL设备和5台原版RhodoLED设备。其在约740家诊所的已安装设备基数达到约801台。
管理层展望
管理层表示,客户在ITC指令生效前提早采购Ameluz导致的订单时间转移,预计不会改变Biofrontera 2026财年全年的营收目标。电话会议上未提供具体的量化营收目标。
Biofrontera继续致力于在2026年实现现金流盈亏平衡。公司计划通过Ameluz的收入增长、剥离XEPI获得的额外100万美元里程碑付款,以及在必要时利用营运资金信贷额度或类似设施来支持流动性。
针对浅表性基底细胞癌,FDA已受理补充新药申请(sNDA),并将PDUFA日期定为2026年9月28日。若获得批准,Biofrontera预计将于2026年第四季度开展初步客户拓展,并利用现有的治疗仪、皮肤科客户和销售团队于2027年第一季度实现全面推出。
公司还计划在2026年第三季度末前后提交补充新药申请,以将日光性角化病的适应症拓展至四肢、颈部和躯干,治疗面积最大可达240平方厘米。管理层预期FDA可能在2027年第三季度批准。
在2b期研究显示Ameluz使炎症性皮损减少58%(而安慰剂组为37%)后,Biofrontera正在评估其痤疮临床项目的下一阶段。未来的临床开发仍取决于可用资金情况。
风险与关注要点
ITC判定RhodoLED XL的部件侵犯了Sun Pharmaceutical的两项专利。有限排除令及停止与禁令已于7月7日生效,禁止Biofrontera进口或销售当前的XL治疗仪,并限制销售用于该设备的Ameluz。
这些限制不影响原版BF-RhodoLED,管理层表示原版设备占已安装设备绝大多数。Biofrontera正在研发一款对铰链部件进行微调的改进版XL治疗仪。据管理层称,该改进已通过FDA相关的CBE-30流程,但公司仍需等待美国边境海关部门确认其不属于ITC指令的限制范围。
Biofrontera在第一季度计入了约50万美元的预估补救费用,管理层表示该预估未发生改变。公司还保留向联邦巡回上诉法院就ITC的裁定提起上诉的权利,但表示其商业计划并不依赖于上诉获胜。
流动性依然紧张。尽管在迈向盈亏平衡方面取得了进展,Biofrontera仍在其财务报表中保留了持续经营警示,并且必须在控制费用的同时继续扩大营收。
分析师问答亮点
管理层表示,针对潜在浅表性基底细胞癌产品推出的准备工作主要包括敲定营销材料、获得FDA预先核准、培训销售团队以及完善报销策略。该适应症将使用公司现有的商业化基础设施。
关于改进后的RhodoLED XL,管理层表示铰链的改动不应对产品性能或医生的使用方式产生明显影响。在改进后的设备通过剩余的边境审查流程后,公司计划为拥有现有XL设备的诊所进行更换安排。
管理层还明确澄清,诊所可以使用在ITC指令生效前购买的Ameluz库存,配合其已拥有的治疗仪使用。然而,在指令生效后,Biofrontera不得额外销售用于涉嫌侵权的RhodoLED XL的Ameluz。
业绩电话会议完整实录
完整财报电话会议逐字稿
管理层陈述
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.
分析师问答
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.









