NASDAQ:MDWD MediWound Q3 2025 Earnings Report $16.57 -0.70 (-4.05%) Closing price 05/8/2026 04:00 PM EasternExtended Trading$16.61 +0.04 (+0.27%) As of 05/8/2026 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast MediWound EPS ResultsActual EPS-$0.24Consensus EPS -$0.81Beat/MissBeat by +$0.57One Year Ago EPSN/AMediWound Revenue ResultsActual Revenue$5.43 millionExpected Revenue$6.56 millionBeat/MissMissed by -$1.13 millionYoY Revenue GrowthN/AMediWound Announcement DetailsQuarterQ3 2025Date11/20/2025TimeBefore Market OpensConference Call DateThursday, November 20, 2025Conference Call Time8:30AM ETUpcoming EarningsMediWound's Q1 2026 earnings is estimated for Wednesday, May 20, 2026, based on past reporting schedulesConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (6-K)Earnings HistoryCompany ProfilePowered by MediWound Q3 2025 Earnings Call TranscriptProvided by QuartrNovember 20, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: EscharEx VALUE Phase III is actively enrolling toward a 216‑patient target across ~40 U.S./EU sites (majority now active), with a DFU program proceeding after positive FDA feedback and planned initiation in H2 2026; an updated market access analysis supports a higher U.S. price and ~$831M peak sales estimate. Positive Sentiment: NexoBrid manufacturing expansion commissioning is complete, boosting capacity ~6x with full operational run-rate expected by year‑end 2025, while Vericel reported record U.S. quarterly revenue (+38% YoY) and international approvals (TGA) continue to drive global momentum. Positive Sentiment: Corporate liquidity was strengthened via a $30M registered direct offering and Series A warrant exercises, leaving MediWound with about $60M in cash and equivalents as of Sept 30, 2025 to fund ongoing programs. Negative Sentiment: Operating expenditures rose (R&D and SG&A) and adjusted EBITDA loss widened (Q3 adjusted EBITDA loss of $5.4M; nine‑month adjusted EBITDA loss $13.9M), and while net loss improved due to non‑cash warrant revaluation, cash used in operations was $15.8M YTD, reflecting increased near‑term burn and funding needs. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallMediWound Q3 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good morning, everyone, and welcome to the MediWound's third quarter 2025 earnings call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one using a touch-tone telephone. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Dan Ferry of LifeSci Advisors. Please go ahead. Dan FerryHead of Investor Relations at LifeSci Advisors00:00:37Thank you, Operator, and welcome, everyone. Earlier today, pre-market open, MediWound issued a press release announcing financial results for the third quarter ended September 30, 2025. You may access this press release on the company's website under the Investors tab. I would ask you to review the full text of our forward-looking statements within this morning's press release. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to MediWound's expected future performance, future business prospects, or future events or plans, are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with the SEC. Dan FerryHead of Investor Relations at LifeSci Advisors00:01:29In addition, all forward-looking statements represent our views only as of today, and MediWound assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. This conference call is the property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. With us today are Ofer Gonen, Chief Executive Officer of MediWound, and Hani Luxenburg, Chief Financial Officer. Barry Wolfenson, EVP of Strategy and Corporate Development, is also participating on today's call. Following our prepared remarks, we will open up the call for Q&A. Now, I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer? Ofer GonenCEO at MediWound00:02:18Hi. Thank you, Dan, and good morning, everyone. The third quarter was another strong period for MediWound as we executed across our strategic, clinical, and operational objectives and continued to position the company for its next phase of growth. The three strategic priorities I'd like to emphasize today are our EscharEx VLU trial, our NexoBrid manufacturing expansion, and our ability to fund our strategy. We have made meaningful progress on all those fronts. Let's start with an update on EscharEx, our late-stage zymatic debridement therapy for chronic wounds. Enrollment in the VALUE Phase III trial in venous leg ulcers continued to progress, with a target of 216 patients across roughly 40 sites in the United States and Europe. U.S. site activation proceeded as planned, while several E.U. sites required additional adjustments to meet ancillary-related regulatory requirements. Overall, the majority of sites are now active and enrolling. Ofer GonenCEO at MediWound00:03:32At this stage, we cannot yet assess whether these E.U.-related adjustments will impact the overall study timeline. We are actively monitoring enrollment trends and will update our guidance if needed as visibility improves. The trial's core primary endpoints are the incidence of complete debridement and the facilitation of wound closure, both measures on which EscharEx demonstrated strong results in previous phase two studies. A pre-specified interim sample size assessment will be conducted after 65% of patients complete the treatment. We have also made progress on the diabetic foot ulcer program. We have received positive FDA feedback, and we are now awaiting EMA scientific advice. The company plans to initiate the study in the second half of 2026. As our VLU and DFU programs move forward, the market around us is also shifting in ways that highlight EschatEx potential. Ofer GonenCEO at MediWound00:04:40Medicare recently lowered reimbursement rates of skin substitute products, which is expected to put significant pressure on that category and close a long-standing payment loophole. In contrast, EscharEx is a biologic regulated under BLA pathway and aims to enter the enzymatic debridement segment where a single legacy product generates roughly $370 million annually. Together, these market changes make EscharEx increasingly attractive to potential strategic partners. To quantify this opportunity, we completed an updated U.S. market access and pricing assessment with an independent global consulting firm, incorporating also input from healthcare professionals and payers. The analysis supports a higher potential U.S. price per course of therapy and estimates annual peak sales of about $831 million. These updated estimates reflect EscharEx's robust clinical data along with modeled health economic benefits derived from earlier wound closure. Ofer GonenCEO at MediWound00:05:58With the VALUE study advancing, a clear regulatory path for DFU, and strong commercial validation, EscharEx is positioned to drive MediWound to the next phase of growth. Now, let's turn the attention to NexoBrid, our innovative enzymatic therapy for severe burns. Most notably, we completed the commissioning of our expanded NexoBrid manufacturing facility, a major milestone that strengthens our ability to meet the rising global demand and maintain reliable supply. The process was not simple. We worked through a two-year war, drafted personnel, and import delays on specialized equipment, but the result is transformative. Our production capacity is now six times larger, providing a strong foundation for future growth. We expect to reach full operational capacity by year-end 2025, with regulatory review and approval determining the timing of commercial output. In the United States, our partner Vericel reported NexoBrid's record quarterly revenue since launch: up 38% year-over-year and 26% sequentially. Ofer GonenCEO at MediWound00:07:23Vericel noted broad utilization across more than 60 burn centers and plans to pursue a permanent CPT code, which would take effect in 2027. Internationally, the TGA in Australia approved NexoBrid for use in both adult and pediatric patients, bringing the total number of approvals to 45 countries worldwide. This approval, together with NexoBrid's prominent presence at the recent European Burn Association Congress, where it was featured in 36 scientific presentations, highlights its expanding clinical recognition and global momentum. Regarding the collaboration with BARDA on an RFP covering stockpiling, development of room temperature-stable formulation, and evaluation of enzymatic debridement products for trauma and blast injury indications, this multi-year program was scheduled to begin on October 1st. As Vericel noted in their recent earnings call, the government shutdown caused all related activities to pause. Ofer GonenCEO at MediWound00:08:33Now that the shutdown has ended, we expect BARDA to resume normal operations and move forward with the planned development and procurement activities. The pause also created some uncertainty around the exact timing of BARDA and DOD-related revenue in Q4. We are actively working on these components, but the final outcome will depend on how activities progress through the remainder of the year. Overall, the advancements we have made with NexoBrid position us to a durable and meaningful growth driver for MediWound. From a corporate standpoint, we recently strengthened our balance sheet with a $30 million of equity financing from high-quality healthcare investors. This transaction provides us with the resources and flexibility to execute on our long-term growth strategy with focus and momentum. Given the discussion around the recent financing, this is a perfect point to transition the call to the financials. Hani? Hani LuxenburgCFO at MediWound00:09:44Thank you, Ofer, and good morning, everyone. Let's turn to our financial results for the third quarter of 2025. Revenue for the quarter was $5.4 million, up 23% year-over-year, compared to $4.4 million for the same period in 2024. The increase was primarily driven by higher development services revenue, including additional contracts with DOD. Gross profit for the quarter was $0.9 million, or 16.5% of revenue, compared to $0.7 million, or 15.5% in the prior year period. R&D expenses were $3.5 million versus $2.5 million in the third quarter of 2024, reflecting increased investment in the EscharEx VALUE Phase III study and related clinical activities. SG&A expenses totaled $4 million, compared to $3.2 million in the same period last year. The increase was primarily due to marketing authorization holder expenses. Operating loss for the quarter was $6.5 million, compared to $5.1 million in the third quarter of 2024. Hani LuxenburgCFO at MediWound00:11:10Net loss was $2.7 million, or $0.24 per share, compared to net loss of $10.3 million, or $0.98 per share in the prior year period. The improvement was mainly driven by non-cash financial income from the revaluation of warrants this quarter, compared to non-cash financial expenses from warrant revaluation in the third quarter of last year. Adjusted EBITDA loss was $5.4 million, compared to a loss of $3.7 million in the third quarter of 2024. Looking at our performance for the first nine months of the year, revenue for the period was $15.1 million, compared to $14.4 million in the same period of 2024. Gross profit was $3 million, or 19.7% of revenue, compared to $1.7 million, or 12% in the first nine months of last year. The margin improvement was driven by a more favorable revenue mix. Hani LuxenburgCFO at MediWound00:12:24R&D expenses were $9.8 million, compared to $5.9 million in the same period of 2024. SG&A expenses were $10.6 million versus $9.1 million in the first nine months of 2024. Operating loss for the period was $17.5 million, compared to $13.3 million last year. Net loss for the first nine months of 2025 was $16.7 million, or $1.53 per share, compared to $26.3 million, or $2.72 per share in the same period of 2024. The reduction in net loss was primarily driven by non-cash financial income from the revaluation of warrants in 2025, compared to non-cash financial expenses from revaluation of warrants in the same period of 2024. Adjusted EBITDA loss for the first nine months was $13.9 million, compared to $9.9 million in the prior year period. Now, turning to our balance sheet. Hani LuxenburgCFO at MediWound00:13:47As of September 30, 2025, we had $60 million in cash, cash equivalent, and short-term deposit, compared to $44 million at year-end 2024. During the first nine months of the year, we used $15.8 million in cash to fund our operating activities. In addition, our balance sheet reflects the completion of a $30 million registered direct offering and $3.5 million in profit from Series A warrant exercises. We believe our current cash position provides the financial flexibility needed to advance our key program and continue executing on our strategic priorities. That concludes my review of the financials. Ofer, back to you. Ofer GonenCEO at MediWound00:14:48Thank you, Hani. To summarize, the third quarter was defined by consistent execution and strategic progress across our programs and operations, clinical advancements with EscharEx, commercial expansion with NexoBrid, and operational readiness for manufacturing infrastructure. With these accomplishments and a solid financial foundation, MediWound is well-positioned for 2026. Operator? Operator00:15:18Ladies and gentlemen, at this time, we'll begin the question-and-answer session. If you would like to ask a question, please press star and then one using a touch-tone telephone. To withdraw your questions, you may press star and two. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the keys to ensure the best sound quality. Once again, that is star and then one to join the question queue. We'll pause momentarily to assemble the roster. Our first question today comes from Josh Jennings from TD Cowen. Please go ahead with your question. Josh JenningsAnalyst at TD Cowen00:15:58Hi. Thanks, Ofer, and Hani. Congrats on continued progress. Just two questions on EscharEx. This first one, new peak sales assumption, I believe, in the U.S. of $830 million+. That's up from prior assumptions, and I know you have a third party working on this. Any help just thinking through what's changed, just volumes increased? Ofer GonenCEO at MediWound00:16:22I'm sorry. Sorry, Josh. Josh, am I the only one who can't hear you well? Josh JenningsAnalyst at TD Cowen00:16:30I'm sorry. Am I coming through better now? Ofer GonenCEO at MediWound00:16:32Oh, yeah, yeah. Now it's better. I'm sorry. Josh JenningsAnalyst at TD Cowen00:16:34I apologize. Ofer GonenCEO at MediWound00:16:35Hi, Josh. You need help? Josh JenningsAnalyst at TD Cowen00:16:37Hi. Ofer GonenCEO at MediWound00:16:37No worries. Josh JenningsAnalyst at TD Cowen00:16:38Thanks for taking the questions, and congrats on the continued progress. I have two questions on EscharEx. Just first on the just new U.S., I think, peak sales estimate, $830 million range, up from $725 million. Can you just share any more details just in terms of some assumptions that are baked in there? Any pricing changes or, I guess, just volumes or patient opportunity assumption deltas from the prior calculation? Ofer GonenCEO at MediWound00:17:11Yeah. Hi, Josh, and really good to speak to you. Barry, can you address that? Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:17:19Yeah. Hi, Josh. Thanks for the question. This analysis that we did was more market access-focused. The respondents skewed more towards payers than they did healthcare providers, as opposed to the previous assessment that we did. Because of that, the focus was really specifically on pricing. Nothing changes with regard to the number of patients, the adoption rates. None of that changes in the model. It all remains the same. The only thing is the pricing. Really, what we focused on was incremental pricing that we would be able to take relative to HEOR benefits. In the initial assessment that we did, where we landed at $725 million for revenues, the price that we used was the baseline price, which was a 15% increase over SANTYL. We had heard that previously. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:18:18We had heard it in Lior, and we heard it in this most recent market research as well. That base case without any HEOR benefits of 15% over SANTYL would stand. When we add in the HEOR benefits, however, it changes a bit. What we found is that the max could go up to as much as 50% over the price of SANTYL. This is the price of the total cost of therapy per patient. What we've done is basically taken what we consider to be a conservative kind of slice of it, somewhere in between the base case and the top case. When we put that into the model, it yields this $831 million of peak sales. Ofer GonenCEO at MediWound00:19:06Understood. Thanks for that. The DFU study looking to kick off enrollment in the second half of next year, you mentioned over some constructive feedback from the FDA. Anything to share just on any nuanced design, trial design updates? Will the same centers that are enrolling the VLU study be investigator sites for the DFU study? Thanks for taking both questions. Josh JenningsAnalyst at TD Cowen00:19:37Yeah. Let me address that. We are not—the easy part is that we are not addressing the same centers. We are working on centers that are specializing with VLU, and there are centers for DFU that are—we are looking at different ones. As for the protocol, as I said in my prepared remark, we are waiting for EMA feedback with the scientific advice, and we will ultimately ensure alignment in both regulators as we finalize the study design. We expect it to happen in weeks, and therefore, we will be able to update about that in the next call. Ofer GonenCEO at MediWound00:20:23Understood. Thanks again. Josh JenningsAnalyst at TD Cowen00:20:25Thank you. Operator00:20:28Our next question comes from R.K. from H.C. Wainwright. Please go ahead with your question. Operator00:20:34Good morning. This is R.K. from H.C. Wainwright. Good afternoon, Ofer, and Hani. I will go back to the question Josh asked a minute ago, but a little bit of a different nuance. Of that $830 million that you are projecting now, just trying to understand the breakdown between DFU and VLU opportunities so that we and the market understand how much weightage you are giving to each of these two indications. I have a couple more questions. Ofer GonenCEO at MediWound00:21:18Barry, maybe you will start with that, and let's see what R.K. has else to ask. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:21:24Sure. Hi, R.K. There are more diabetic foot ulcers than there are venous leg ulcers. The reason why we're doing venous leg ulcers first is, frankly, because of the pain issue. They're very, very painful, and it makes it so that they're less likely to be debrided with surgical debridement. Our alternative provides a really good solution. We do believe, even though DFUs could be debrided with surgical debridement, and they more often than not have peripheral neuropathy, and so the pain is not an issue, that because EscharEx reduces the time to complete debridement dramatically versus the enzymatic debrider that's in the market right now, that there will be share gain there as well. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:22:16I think if you look at the split with the puts and the takes, it comes out to roughly even with a little bit of an advantage, a little bit of a weighting on the venous leg ulcer side. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:22:29Thank you for that. Ofer, in your remarks, at least the way I understood your commentary on the RFP with BARDA, it looks like you almost met with success or it has been successful. Is that true? I understand the U.S. government has not been helpful having had the shutdown. Is there any indication as to how soon this could start for you folks? The last question for me is on the CPT code itself. Any nuances you can give us about how not having a CPT code, is it impacting any adoption at all, or does this just add more help once you get the adoption, get the CPT code on board? Josh JenningsAnalyst at TD Cowen00:23:48Let me break down the answers into two parts. I will start with BARDA, and Barry will speak on the code. In BARDA, I'll tell you the maximum that I'm allowed to share. As you all know, in August 2025, BARDA issued an RFP covering stockpiling, room temperature stable formulation, and trauma blast injury solutions. We were ready to start the program on October 1st. It's a program that is supposed to extend for up to 10 years. Vericel holds the commercial rights of NexoBrid in the United States, so they're leading the effort in the United States, and MediWound is providing full support for that. Now, when the shutdown ends, we expect BARDA to resume the normal operations and move forward with the planned development and procurement activities. Other than that, I cannot tell you a time. Hopefully, very soon. Josh JenningsAnalyst at TD Cowen00:24:52Barry, do you want to speak about the CPT? Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:24:55Yeah. From a CPT code perspective, hi R.K. I guess first, let me preface this by saying that Vericel, while they mentioned the fact that, A, they have a temporary CPT code that went into effect, I think it was July 1st, and that based on the utilization that they're having, which has been strong, they believe that they'll be able to, in 2026, apply for a permanent CPT code that would then be activated in 2027 if all goes well. They haven't really talked about what those benefits are and provided those nuances that you're looking for. These are just our thoughts on it, how those could be helpful. I guess what I would say is, generally speaking, we all know that these procedures are done inpatient, which is through the DRG, but CPT codes do help in a couple of different areas, really about providing legitimacy. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:25:52One is it provides legitimacy nationally at the national level, which can drive physician adoption. What I mean by legitimacy, it provides those CPT codes provide a standardized language for the procedure. It helps with internal approval pathways, conventional frameworks, and also just with workflow legitimacy. All of that, this legitimacy boosts physician acceptance. When the physicians are more confident that they could do a procedure and that it's going to have the right coding associated with it, it could increase patient use, again, even though the payment mechanism is DRG-based. Secondly, it drives institutional acceptance. Having these CPT codes in place, I mean, without them, institutions might hesitate to put on contract any new technologies. They are helpful having them in place with the P&T committees, the value analysis, EMR pathway creation. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:26:52Having the CPT codes just makes it easier for burn centers to approve NexoBrid. I know that Vericel talked about 60+ burn centers, and there are around 100 of these sort of grade A burn centers that they're targeting. There is a little bit more to go. Maybe as they get a permanent CPT code, it'll just make things easier to get the laggards on board and have NexoBrid on contract. That is the way that we see it, is they've got a temporary, but a more permanent CPT code just adds to that legitimacy and would help drive both physician adoption and institutional acceptance. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:27:31Thank you very much. Thanks for taking all my questions. Ofer GonenCEO at MediWound00:27:35Thank you. Operator00:27:37Our next question comes from Jeff Jones from Oppenheimer. Please go ahead with your question. Jeff JonesAnalyst at Oppenheimer00:27:42Good afternoon, guys, and thanks for taking the question. A couple from us. Can you provide any additional visibility on the breakdown of the $5.4 million in revenue? You noted increased margin based on Vericel sales, I assume, but just the breakdown between product, services, and revenues? Hani LuxenburgCFO at MediWound00:28:15Hi, Jeff. Thank you for the question. In the third quarter, we only give the press release with the condensed numbers of P&L. We do not give a full financial statement, only in the second quarter and, of course, at the end of the year. I cannot tell you more than that. Anyway, I can tell you that the gross margin is much, as you know, the gross margin this quarter was around 20%. It was up from 12% last year. This improvement is reflecting a more favorable change in our revenue mix. In any way, our gross margin also is affected by a mix of revenue from product sales and the R&D services. We expect our gross margin to move, as you know, gradually toward the 25% in full capacity, 65%. Jeff JonesAnalyst at Oppenheimer00:29:13Great. Appreciate that, Hani. Two additional questions. Just on the U.S. government contract discussions with BARDA, obviously, that is with Vericel. Just for clarity, the BARDA contract hasn't been awarded, correct? The second BARDA contract. Josh JenningsAnalyst at TD Cowen00:29:45Yeah. There was an RFP for a 10-year contract covering stockpiling, room temperature stable formulations, and trauma blast injury solutions. Vericel disclosed in their previous earnings that they submitted a proposal to the U.S. government, and we are waiting for the contract to be signed. Jeff JonesAnalyst at Oppenheimer00:30:15Great. I look forward to finding out about base options and sort of period of work there. Just any update on the commercialization plans and expansion into Europe? Josh JenningsAnalyst at TD Cowen00:30:31Currently, as you know, we are capped by our ability to manufacture. We have much more demand than we can basically manufacture and ship towards the territories. Having said that, we expect that by year-end 2025, our manufacturing facility will be fully, fully operational, and we can start actually manufacturing for the markets. As the demand is extremely higher, we believe that after that, we can disclose our commercial plans for that. Jeff JonesAnalyst at Oppenheimer00:31:12Great. Thank you very much, guys. Josh JenningsAnalyst at TD Cowen00:31:15Thank you. Operator00:31:17Once again, if you would like to ask a question, please press star and then one. To withdraw your questions, you may press star and two. Again, that is star and then one to join the question queue. Our next question comes from Michael Okunewitch from Maxim Group. Please go ahead with your question. Michael OkunewitchAnalyst at Maxim Group00:31:38Hey, guys. Thank you so much for taking my questions today. I guess to start off, I just wanted to follow up on some of the previous questions around the pricing and the new health economic analysis. In particular, what endpoints are most relevant to the health economic benefit? Are there any specific thresholds in the phase three that we should look to that could justify that upside pricing? Jeff JonesAnalyst at Oppenheimer00:32:08Let's see. Josh JenningsAnalyst at TD Cowen00:32:10Hi, Michael. Thank you for joining the call. I see that Barry wants to answer that. Right, Barry? Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:32:18Yes. That's a great couple of questions there. Let me do the best I can to answer. Basically, all the HEOR that we looked at in this assessment, or that, frankly, the payers guided us to really think about, is this benefit that will be associated with early wound closure. When you think about it, if you've got a wound that's open for six to 10 weeks longer, whatever the time frame is, there's all sorts of whether it's the nursing time, physician time, the product time, and then all the risks that are associated with it: infection, hospitalization, anything else that needs to be done, any kind of corrective treatments that come up due to the wound not progressing well. All of those costs bundled together represent some amount of savings. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:33:18There's already pretty good publicly available published information on what is considered to be the average cost per week of an open venous leg ulcer. Between what we generate from our endpoint of early closure, data that we generate, because we will look to create our own set of data around the cost of an open leg ulcer, that in combination with what's already been published will drive this total amount. As far as the cap is concerned, I will say that consistent feedback that we got from payers is that the product that's the legacy product in the market right now, SANTYL, has taken a price increase very consistently. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:34:10I don't know that it's been every year, but it's been somewhat consistently such that, for example, a 30 g tube has gone from roughly, again, an estimate around $100 for a 30 g tube to around $300 over the course of these last 10+ years. There was some feedback that there would be a cap at this roughly 50% premium over SANTYL, even though that additional amount might only be a small portion of the actual HEOR benefits that are derived. That's how we're modeling it. What I said earlier is we're taking a conservative approach to that even. For our own modeling and this number that we've pushed out at 831, it really isn't that top price. It's a price that's in between that top price of 50% premium over SANTYL and the 15% premium over SANTYL. Michael OkunewitchAnalyst at Maxim Group00:35:06Thank you for that. Michael OkunewitchAnalyst at Maxim Group00:35:12Just one more from me, and I'll hop back into the queue. In light of the recent updates to your market research, I want to ask a bit of an opposite question. We all on this call know the significant benefits that would draw converts over to EscharEx. What are the factors that would lead people or lead physicians to opt for other methods like sharp or autolytic? I'm trying to understand if there are any hard limits for EscharEx in this setting beyond that 22.3% conversion estimate that you use. Josh JenningsAnalyst at TD Cowen00:35:47Barry, take this one as well. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:35:49Yeah. Yeah. Thanks. Listen, I think that there are still going to be situations, in particular, as I mentioned earlier, due to peripheral neuropathy in the diabetic foot ulcer segment, where it just might be easier for physicians to clean up a wound once or twice with a knife as opposed to several days of drug application. On the sharp side, it is the standard of care now. We do estimate taking around 10% of that of the utilization from sharp debridement, but there's still going to be a market for sharp debridement. This is not as one-to-one analogous as NexoBrid is with burns, where it can completely obviate the need for surgery. This is a little more soft in the chronic wound space. Again, that's why I say we estimate around 10% on the sharp side. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:36:51On the Autolytic side, it's just Autolytic debridement is so much less expensive that it depends on the setting, the case situation, the patient's insurance. There's still going to be a market for Autolytic debridement. Again, we believe that we're going to take a significant share from current Autolytic debridement. Right now, the legacy product relative to Autolytic debridement, you could look it up in the published literature, whether there's an advantage or not, but there's certainly a significant pricing differential, we believe, on that sort of ratio of price per clinical efficacy that we're going to hit a sweet spot and that it's going to encourage much more widespread adoption. There'll still be a market for it for Autolytic. Michael OkunewitchAnalyst at Maxim Group00:37:39Thank you. I really appreciate the additional insights. Once again, congrats on all the progress this quarter. Josh JenningsAnalyst at TD Cowen00:37:47Thank you, Michael. Operator00:37:51Ladies and gentlemen, with that, we will be ending today's question and answer session. I'd like to turn the floor back over to Ofer Gonen for closing remarks. Ofer GonenCEO at MediWound00:38:04Thank you, everyone, for joining us today, and we look forward to updating you again on our next quarterly call. Operator00:38:13With that, ladies and gentlemen, we will be concluding today's conference call. We do thank you for attending today's presentation. You may now disconnect your lines.Read moreParticipantsExecutivesBarry WolfensonEVP of Strategy and Corporate DevelopmentOfer GonenCEOHani LuxenburgCFOAnalystsMichael OkunewitchAnalyst at Maxim GroupJosh JenningsAnalyst at TD CowenDan FerryHead of Investor Relations at LifeSci AdvisorsAnalyst at H.C. Wainwright & CoJeff JonesAnalyst at OppenheimerPowered by Earnings Documents MediWound Earnings HeadlinesMediWound to Report First Quarter 2026 Financial ResultsMay 7 at 8:00 AM | globenewswire.comMediWound Shareholders Back Board, Auditor and CEO Bonus at 2026 Annual MeetingMay 6 at 4:51 PM | tipranks.com$30 stock to buy before Starlink goes public (WATCH NOW!)In the next 3 minutes… James Altucher – legendary investor and venture capitalist… And someone who’s known for playing his cards “close to the vest”… Is going to give you the name and ticker symbol of a company he believes will skyrocket thanks to the coming Starlink IPO… | Paradigm Press (Ad)Analysts Offer Insights on Healthcare Companies: Simulations Plus (SLP) and Mediwound (MDWD)April 16, 2026 | theglobeandmail.comNewly Published U.S. Expert Consensus Aligns with MediWound’s Strategy for Chronic Wound DebridementApril 13, 2026 | markets.businessinsider.comNewly Published U.S. Expert Consensus Aligns with MediWound's Strategy for Chronic Wound DebridementApril 13, 2026 | globenewswire.comSee More MediWound Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like MediWound? Sign up for Earnings360's daily newsletter to receive timely earnings updates on MediWound and other key companies, straight to your email. Email Address About MediWoundMediWound (NASDAQ:MDWD) (NASDAQ: MDWD) is a biopharmaceutical company headquartered in Yavne, Israel, specializing in the development and commercialization of innovative enzymatic therapies for burn and wound management. Since its establishment, the company has focused on advancing proteolytic enzyme technology to address critical needs in debridement and tissue repair. MediWound operates research and development facilities in Israel and maintains commercial offices in the United States to support its global market presence. The company’s lead product, NexoBrid®, is an enzyme-based debriding agent designed to selectively remove burn eschar without harming viable tissue. NexoBrid has received regulatory approval in the European Union and by the U.S. Food and Drug Administration for use in adults with severe thermal burns. MediWound is also advancing EscharEx™, a topical therapy aimed at debriding chronic and hard-to-heal wounds, currently undergoing pivotal clinical trials to expand its therapeutic portfolio. MediWound’s commercial reach spans North America, Europe and other international markets through a network of strategic distribution partners. In the United States, the company supports its sales efforts with a dedicated subsidiary and field-based clinical specialists, while in Europe it works with established distributors to ensure product availability and regulatory compliance. The company continues to explore additional indications and territories to broaden access to its enzymatic treatments. Leadership at MediWound is spearheaded by Chief Executive Officer Dan Rosenwasser, who has guided the company’s strategic expansion and commercialization initiatives. Under his direction, MediWound has strengthened its manufacturing capabilities and fortified its clinical pipeline. The management team’s combined expertise in biotechnology, regulatory affairs and commercial operations underpins the company’s mission to deliver advanced wound care solutions to patients worldwide.View MediWound ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Rocket Lab Posts Record Q1 Revenue, Raises Q2 GuidanceHims & Hers Earnings Preview: The Novo Nordisk Shift Puts GLP-1 Strategy in FocusAppLovin Pops After Earnings With Growth Catalysts in SightDutch Bros Q1 Earnings: The Newest Starbucks Rival Faces Its First Big Reality CheckThe AI Fear Around Datadog Stock May Have Been Completely WrongAmprius Technologies Ups the Voltage on Forward OutlookWhy Lam Research Still Looks Like a Buy After a 300% Rally Upcoming Earnings Constellation Energy (5/11/2026)Barrick Mining (5/11/2026)Petroleo Brasileiro S.A.- Petrobras (5/11/2026)Simon Property Group (5/11/2026)SEA (5/12/2026)Cisco Systems (5/13/2026)Alibaba Group (5/13/2026)Manulife Financial (5/13/2026)Sumitomo Mitsui Financial Group (5/13/2026)Takeda Pharmaceutical (5/13/2026) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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PresentationSkip to Participants Operator00:00:00Good morning, everyone, and welcome to the MediWound's third quarter 2025 earnings call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one using a touch-tone telephone. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Dan Ferry of LifeSci Advisors. Please go ahead. Dan FerryHead of Investor Relations at LifeSci Advisors00:00:37Thank you, Operator, and welcome, everyone. Earlier today, pre-market open, MediWound issued a press release announcing financial results for the third quarter ended September 30, 2025. You may access this press release on the company's website under the Investors tab. I would ask you to review the full text of our forward-looking statements within this morning's press release. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to MediWound's expected future performance, future business prospects, or future events or plans, are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with the SEC. Dan FerryHead of Investor Relations at LifeSci Advisors00:01:29In addition, all forward-looking statements represent our views only as of today, and MediWound assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. This conference call is the property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. With us today are Ofer Gonen, Chief Executive Officer of MediWound, and Hani Luxenburg, Chief Financial Officer. Barry Wolfenson, EVP of Strategy and Corporate Development, is also participating on today's call. Following our prepared remarks, we will open up the call for Q&A. Now, I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer? Ofer GonenCEO at MediWound00:02:18Hi. Thank you, Dan, and good morning, everyone. The third quarter was another strong period for MediWound as we executed across our strategic, clinical, and operational objectives and continued to position the company for its next phase of growth. The three strategic priorities I'd like to emphasize today are our EscharEx VLU trial, our NexoBrid manufacturing expansion, and our ability to fund our strategy. We have made meaningful progress on all those fronts. Let's start with an update on EscharEx, our late-stage zymatic debridement therapy for chronic wounds. Enrollment in the VALUE Phase III trial in venous leg ulcers continued to progress, with a target of 216 patients across roughly 40 sites in the United States and Europe. U.S. site activation proceeded as planned, while several E.U. sites required additional adjustments to meet ancillary-related regulatory requirements. Overall, the majority of sites are now active and enrolling. Ofer GonenCEO at MediWound00:03:32At this stage, we cannot yet assess whether these E.U.-related adjustments will impact the overall study timeline. We are actively monitoring enrollment trends and will update our guidance if needed as visibility improves. The trial's core primary endpoints are the incidence of complete debridement and the facilitation of wound closure, both measures on which EscharEx demonstrated strong results in previous phase two studies. A pre-specified interim sample size assessment will be conducted after 65% of patients complete the treatment. We have also made progress on the diabetic foot ulcer program. We have received positive FDA feedback, and we are now awaiting EMA scientific advice. The company plans to initiate the study in the second half of 2026. As our VLU and DFU programs move forward, the market around us is also shifting in ways that highlight EschatEx potential. Ofer GonenCEO at MediWound00:04:40Medicare recently lowered reimbursement rates of skin substitute products, which is expected to put significant pressure on that category and close a long-standing payment loophole. In contrast, EscharEx is a biologic regulated under BLA pathway and aims to enter the enzymatic debridement segment where a single legacy product generates roughly $370 million annually. Together, these market changes make EscharEx increasingly attractive to potential strategic partners. To quantify this opportunity, we completed an updated U.S. market access and pricing assessment with an independent global consulting firm, incorporating also input from healthcare professionals and payers. The analysis supports a higher potential U.S. price per course of therapy and estimates annual peak sales of about $831 million. These updated estimates reflect EscharEx's robust clinical data along with modeled health economic benefits derived from earlier wound closure. Ofer GonenCEO at MediWound00:05:58With the VALUE study advancing, a clear regulatory path for DFU, and strong commercial validation, EscharEx is positioned to drive MediWound to the next phase of growth. Now, let's turn the attention to NexoBrid, our innovative enzymatic therapy for severe burns. Most notably, we completed the commissioning of our expanded NexoBrid manufacturing facility, a major milestone that strengthens our ability to meet the rising global demand and maintain reliable supply. The process was not simple. We worked through a two-year war, drafted personnel, and import delays on specialized equipment, but the result is transformative. Our production capacity is now six times larger, providing a strong foundation for future growth. We expect to reach full operational capacity by year-end 2025, with regulatory review and approval determining the timing of commercial output. In the United States, our partner Vericel reported NexoBrid's record quarterly revenue since launch: up 38% year-over-year and 26% sequentially. Ofer GonenCEO at MediWound00:07:23Vericel noted broad utilization across more than 60 burn centers and plans to pursue a permanent CPT code, which would take effect in 2027. Internationally, the TGA in Australia approved NexoBrid for use in both adult and pediatric patients, bringing the total number of approvals to 45 countries worldwide. This approval, together with NexoBrid's prominent presence at the recent European Burn Association Congress, where it was featured in 36 scientific presentations, highlights its expanding clinical recognition and global momentum. Regarding the collaboration with BARDA on an RFP covering stockpiling, development of room temperature-stable formulation, and evaluation of enzymatic debridement products for trauma and blast injury indications, this multi-year program was scheduled to begin on October 1st. As Vericel noted in their recent earnings call, the government shutdown caused all related activities to pause. Ofer GonenCEO at MediWound00:08:33Now that the shutdown has ended, we expect BARDA to resume normal operations and move forward with the planned development and procurement activities. The pause also created some uncertainty around the exact timing of BARDA and DOD-related revenue in Q4. We are actively working on these components, but the final outcome will depend on how activities progress through the remainder of the year. Overall, the advancements we have made with NexoBrid position us to a durable and meaningful growth driver for MediWound. From a corporate standpoint, we recently strengthened our balance sheet with a $30 million of equity financing from high-quality healthcare investors. This transaction provides us with the resources and flexibility to execute on our long-term growth strategy with focus and momentum. Given the discussion around the recent financing, this is a perfect point to transition the call to the financials. Hani? Hani LuxenburgCFO at MediWound00:09:44Thank you, Ofer, and good morning, everyone. Let's turn to our financial results for the third quarter of 2025. Revenue for the quarter was $5.4 million, up 23% year-over-year, compared to $4.4 million for the same period in 2024. The increase was primarily driven by higher development services revenue, including additional contracts with DOD. Gross profit for the quarter was $0.9 million, or 16.5% of revenue, compared to $0.7 million, or 15.5% in the prior year period. R&D expenses were $3.5 million versus $2.5 million in the third quarter of 2024, reflecting increased investment in the EscharEx VALUE Phase III study and related clinical activities. SG&A expenses totaled $4 million, compared to $3.2 million in the same period last year. The increase was primarily due to marketing authorization holder expenses. Operating loss for the quarter was $6.5 million, compared to $5.1 million in the third quarter of 2024. Hani LuxenburgCFO at MediWound00:11:10Net loss was $2.7 million, or $0.24 per share, compared to net loss of $10.3 million, or $0.98 per share in the prior year period. The improvement was mainly driven by non-cash financial income from the revaluation of warrants this quarter, compared to non-cash financial expenses from warrant revaluation in the third quarter of last year. Adjusted EBITDA loss was $5.4 million, compared to a loss of $3.7 million in the third quarter of 2024. Looking at our performance for the first nine months of the year, revenue for the period was $15.1 million, compared to $14.4 million in the same period of 2024. Gross profit was $3 million, or 19.7% of revenue, compared to $1.7 million, or 12% in the first nine months of last year. The margin improvement was driven by a more favorable revenue mix. Hani LuxenburgCFO at MediWound00:12:24R&D expenses were $9.8 million, compared to $5.9 million in the same period of 2024. SG&A expenses were $10.6 million versus $9.1 million in the first nine months of 2024. Operating loss for the period was $17.5 million, compared to $13.3 million last year. Net loss for the first nine months of 2025 was $16.7 million, or $1.53 per share, compared to $26.3 million, or $2.72 per share in the same period of 2024. The reduction in net loss was primarily driven by non-cash financial income from the revaluation of warrants in 2025, compared to non-cash financial expenses from revaluation of warrants in the same period of 2024. Adjusted EBITDA loss for the first nine months was $13.9 million, compared to $9.9 million in the prior year period. Now, turning to our balance sheet. Hani LuxenburgCFO at MediWound00:13:47As of September 30, 2025, we had $60 million in cash, cash equivalent, and short-term deposit, compared to $44 million at year-end 2024. During the first nine months of the year, we used $15.8 million in cash to fund our operating activities. In addition, our balance sheet reflects the completion of a $30 million registered direct offering and $3.5 million in profit from Series A warrant exercises. We believe our current cash position provides the financial flexibility needed to advance our key program and continue executing on our strategic priorities. That concludes my review of the financials. Ofer, back to you. Ofer GonenCEO at MediWound00:14:48Thank you, Hani. To summarize, the third quarter was defined by consistent execution and strategic progress across our programs and operations, clinical advancements with EscharEx, commercial expansion with NexoBrid, and operational readiness for manufacturing infrastructure. With these accomplishments and a solid financial foundation, MediWound is well-positioned for 2026. Operator? Operator00:15:18Ladies and gentlemen, at this time, we'll begin the question-and-answer session. If you would like to ask a question, please press star and then one using a touch-tone telephone. To withdraw your questions, you may press star and two. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the keys to ensure the best sound quality. Once again, that is star and then one to join the question queue. We'll pause momentarily to assemble the roster. Our first question today comes from Josh Jennings from TD Cowen. Please go ahead with your question. Josh JenningsAnalyst at TD Cowen00:15:58Hi. Thanks, Ofer, and Hani. Congrats on continued progress. Just two questions on EscharEx. This first one, new peak sales assumption, I believe, in the U.S. of $830 million+. That's up from prior assumptions, and I know you have a third party working on this. Any help just thinking through what's changed, just volumes increased? Ofer GonenCEO at MediWound00:16:22I'm sorry. Sorry, Josh. Josh, am I the only one who can't hear you well? Josh JenningsAnalyst at TD Cowen00:16:30I'm sorry. Am I coming through better now? Ofer GonenCEO at MediWound00:16:32Oh, yeah, yeah. Now it's better. I'm sorry. Josh JenningsAnalyst at TD Cowen00:16:34I apologize. Ofer GonenCEO at MediWound00:16:35Hi, Josh. You need help? Josh JenningsAnalyst at TD Cowen00:16:37Hi. Ofer GonenCEO at MediWound00:16:37No worries. Josh JenningsAnalyst at TD Cowen00:16:38Thanks for taking the questions, and congrats on the continued progress. I have two questions on EscharEx. Just first on the just new U.S., I think, peak sales estimate, $830 million range, up from $725 million. Can you just share any more details just in terms of some assumptions that are baked in there? Any pricing changes or, I guess, just volumes or patient opportunity assumption deltas from the prior calculation? Ofer GonenCEO at MediWound00:17:11Yeah. Hi, Josh, and really good to speak to you. Barry, can you address that? Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:17:19Yeah. Hi, Josh. Thanks for the question. This analysis that we did was more market access-focused. The respondents skewed more towards payers than they did healthcare providers, as opposed to the previous assessment that we did. Because of that, the focus was really specifically on pricing. Nothing changes with regard to the number of patients, the adoption rates. None of that changes in the model. It all remains the same. The only thing is the pricing. Really, what we focused on was incremental pricing that we would be able to take relative to HEOR benefits. In the initial assessment that we did, where we landed at $725 million for revenues, the price that we used was the baseline price, which was a 15% increase over SANTYL. We had heard that previously. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:18:18We had heard it in Lior, and we heard it in this most recent market research as well. That base case without any HEOR benefits of 15% over SANTYL would stand. When we add in the HEOR benefits, however, it changes a bit. What we found is that the max could go up to as much as 50% over the price of SANTYL. This is the price of the total cost of therapy per patient. What we've done is basically taken what we consider to be a conservative kind of slice of it, somewhere in between the base case and the top case. When we put that into the model, it yields this $831 million of peak sales. Ofer GonenCEO at MediWound00:19:06Understood. Thanks for that. The DFU study looking to kick off enrollment in the second half of next year, you mentioned over some constructive feedback from the FDA. Anything to share just on any nuanced design, trial design updates? Will the same centers that are enrolling the VLU study be investigator sites for the DFU study? Thanks for taking both questions. Josh JenningsAnalyst at TD Cowen00:19:37Yeah. Let me address that. We are not—the easy part is that we are not addressing the same centers. We are working on centers that are specializing with VLU, and there are centers for DFU that are—we are looking at different ones. As for the protocol, as I said in my prepared remark, we are waiting for EMA feedback with the scientific advice, and we will ultimately ensure alignment in both regulators as we finalize the study design. We expect it to happen in weeks, and therefore, we will be able to update about that in the next call. Ofer GonenCEO at MediWound00:20:23Understood. Thanks again. Josh JenningsAnalyst at TD Cowen00:20:25Thank you. Operator00:20:28Our next question comes from R.K. from H.C. Wainwright. Please go ahead with your question. Operator00:20:34Good morning. This is R.K. from H.C. Wainwright. Good afternoon, Ofer, and Hani. I will go back to the question Josh asked a minute ago, but a little bit of a different nuance. Of that $830 million that you are projecting now, just trying to understand the breakdown between DFU and VLU opportunities so that we and the market understand how much weightage you are giving to each of these two indications. I have a couple more questions. Ofer GonenCEO at MediWound00:21:18Barry, maybe you will start with that, and let's see what R.K. has else to ask. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:21:24Sure. Hi, R.K. There are more diabetic foot ulcers than there are venous leg ulcers. The reason why we're doing venous leg ulcers first is, frankly, because of the pain issue. They're very, very painful, and it makes it so that they're less likely to be debrided with surgical debridement. Our alternative provides a really good solution. We do believe, even though DFUs could be debrided with surgical debridement, and they more often than not have peripheral neuropathy, and so the pain is not an issue, that because EscharEx reduces the time to complete debridement dramatically versus the enzymatic debrider that's in the market right now, that there will be share gain there as well. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:22:16I think if you look at the split with the puts and the takes, it comes out to roughly even with a little bit of an advantage, a little bit of a weighting on the venous leg ulcer side. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:22:29Thank you for that. Ofer, in your remarks, at least the way I understood your commentary on the RFP with BARDA, it looks like you almost met with success or it has been successful. Is that true? I understand the U.S. government has not been helpful having had the shutdown. Is there any indication as to how soon this could start for you folks? The last question for me is on the CPT code itself. Any nuances you can give us about how not having a CPT code, is it impacting any adoption at all, or does this just add more help once you get the adoption, get the CPT code on board? Josh JenningsAnalyst at TD Cowen00:23:48Let me break down the answers into two parts. I will start with BARDA, and Barry will speak on the code. In BARDA, I'll tell you the maximum that I'm allowed to share. As you all know, in August 2025, BARDA issued an RFP covering stockpiling, room temperature stable formulation, and trauma blast injury solutions. We were ready to start the program on October 1st. It's a program that is supposed to extend for up to 10 years. Vericel holds the commercial rights of NexoBrid in the United States, so they're leading the effort in the United States, and MediWound is providing full support for that. Now, when the shutdown ends, we expect BARDA to resume the normal operations and move forward with the planned development and procurement activities. Other than that, I cannot tell you a time. Hopefully, very soon. Josh JenningsAnalyst at TD Cowen00:24:52Barry, do you want to speak about the CPT? Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:24:55Yeah. From a CPT code perspective, hi R.K. I guess first, let me preface this by saying that Vericel, while they mentioned the fact that, A, they have a temporary CPT code that went into effect, I think it was July 1st, and that based on the utilization that they're having, which has been strong, they believe that they'll be able to, in 2026, apply for a permanent CPT code that would then be activated in 2027 if all goes well. They haven't really talked about what those benefits are and provided those nuances that you're looking for. These are just our thoughts on it, how those could be helpful. I guess what I would say is, generally speaking, we all know that these procedures are done inpatient, which is through the DRG, but CPT codes do help in a couple of different areas, really about providing legitimacy. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:25:52One is it provides legitimacy nationally at the national level, which can drive physician adoption. What I mean by legitimacy, it provides those CPT codes provide a standardized language for the procedure. It helps with internal approval pathways, conventional frameworks, and also just with workflow legitimacy. All of that, this legitimacy boosts physician acceptance. When the physicians are more confident that they could do a procedure and that it's going to have the right coding associated with it, it could increase patient use, again, even though the payment mechanism is DRG-based. Secondly, it drives institutional acceptance. Having these CPT codes in place, I mean, without them, institutions might hesitate to put on contract any new technologies. They are helpful having them in place with the P&T committees, the value analysis, EMR pathway creation. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:26:52Having the CPT codes just makes it easier for burn centers to approve NexoBrid. I know that Vericel talked about 60+ burn centers, and there are around 100 of these sort of grade A burn centers that they're targeting. There is a little bit more to go. Maybe as they get a permanent CPT code, it'll just make things easier to get the laggards on board and have NexoBrid on contract. That is the way that we see it, is they've got a temporary, but a more permanent CPT code just adds to that legitimacy and would help drive both physician adoption and institutional acceptance. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:27:31Thank you very much. Thanks for taking all my questions. Ofer GonenCEO at MediWound00:27:35Thank you. Operator00:27:37Our next question comes from Jeff Jones from Oppenheimer. Please go ahead with your question. Jeff JonesAnalyst at Oppenheimer00:27:42Good afternoon, guys, and thanks for taking the question. A couple from us. Can you provide any additional visibility on the breakdown of the $5.4 million in revenue? You noted increased margin based on Vericel sales, I assume, but just the breakdown between product, services, and revenues? Hani LuxenburgCFO at MediWound00:28:15Hi, Jeff. Thank you for the question. In the third quarter, we only give the press release with the condensed numbers of P&L. We do not give a full financial statement, only in the second quarter and, of course, at the end of the year. I cannot tell you more than that. Anyway, I can tell you that the gross margin is much, as you know, the gross margin this quarter was around 20%. It was up from 12% last year. This improvement is reflecting a more favorable change in our revenue mix. In any way, our gross margin also is affected by a mix of revenue from product sales and the R&D services. We expect our gross margin to move, as you know, gradually toward the 25% in full capacity, 65%. Jeff JonesAnalyst at Oppenheimer00:29:13Great. Appreciate that, Hani. Two additional questions. Just on the U.S. government contract discussions with BARDA, obviously, that is with Vericel. Just for clarity, the BARDA contract hasn't been awarded, correct? The second BARDA contract. Josh JenningsAnalyst at TD Cowen00:29:45Yeah. There was an RFP for a 10-year contract covering stockpiling, room temperature stable formulations, and trauma blast injury solutions. Vericel disclosed in their previous earnings that they submitted a proposal to the U.S. government, and we are waiting for the contract to be signed. Jeff JonesAnalyst at Oppenheimer00:30:15Great. I look forward to finding out about base options and sort of period of work there. Just any update on the commercialization plans and expansion into Europe? Josh JenningsAnalyst at TD Cowen00:30:31Currently, as you know, we are capped by our ability to manufacture. We have much more demand than we can basically manufacture and ship towards the territories. Having said that, we expect that by year-end 2025, our manufacturing facility will be fully, fully operational, and we can start actually manufacturing for the markets. As the demand is extremely higher, we believe that after that, we can disclose our commercial plans for that. Jeff JonesAnalyst at Oppenheimer00:31:12Great. Thank you very much, guys. Josh JenningsAnalyst at TD Cowen00:31:15Thank you. Operator00:31:17Once again, if you would like to ask a question, please press star and then one. To withdraw your questions, you may press star and two. Again, that is star and then one to join the question queue. Our next question comes from Michael Okunewitch from Maxim Group. Please go ahead with your question. Michael OkunewitchAnalyst at Maxim Group00:31:38Hey, guys. Thank you so much for taking my questions today. I guess to start off, I just wanted to follow up on some of the previous questions around the pricing and the new health economic analysis. In particular, what endpoints are most relevant to the health economic benefit? Are there any specific thresholds in the phase three that we should look to that could justify that upside pricing? Jeff JonesAnalyst at Oppenheimer00:32:08Let's see. Josh JenningsAnalyst at TD Cowen00:32:10Hi, Michael. Thank you for joining the call. I see that Barry wants to answer that. Right, Barry? Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:32:18Yes. That's a great couple of questions there. Let me do the best I can to answer. Basically, all the HEOR that we looked at in this assessment, or that, frankly, the payers guided us to really think about, is this benefit that will be associated with early wound closure. When you think about it, if you've got a wound that's open for six to 10 weeks longer, whatever the time frame is, there's all sorts of whether it's the nursing time, physician time, the product time, and then all the risks that are associated with it: infection, hospitalization, anything else that needs to be done, any kind of corrective treatments that come up due to the wound not progressing well. All of those costs bundled together represent some amount of savings. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:33:18There's already pretty good publicly available published information on what is considered to be the average cost per week of an open venous leg ulcer. Between what we generate from our endpoint of early closure, data that we generate, because we will look to create our own set of data around the cost of an open leg ulcer, that in combination with what's already been published will drive this total amount. As far as the cap is concerned, I will say that consistent feedback that we got from payers is that the product that's the legacy product in the market right now, SANTYL, has taken a price increase very consistently. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:34:10I don't know that it's been every year, but it's been somewhat consistently such that, for example, a 30 g tube has gone from roughly, again, an estimate around $100 for a 30 g tube to around $300 over the course of these last 10+ years. There was some feedback that there would be a cap at this roughly 50% premium over SANTYL, even though that additional amount might only be a small portion of the actual HEOR benefits that are derived. That's how we're modeling it. What I said earlier is we're taking a conservative approach to that even. For our own modeling and this number that we've pushed out at 831, it really isn't that top price. It's a price that's in between that top price of 50% premium over SANTYL and the 15% premium over SANTYL. Michael OkunewitchAnalyst at Maxim Group00:35:06Thank you for that. Michael OkunewitchAnalyst at Maxim Group00:35:12Just one more from me, and I'll hop back into the queue. In light of the recent updates to your market research, I want to ask a bit of an opposite question. We all on this call know the significant benefits that would draw converts over to EscharEx. What are the factors that would lead people or lead physicians to opt for other methods like sharp or autolytic? I'm trying to understand if there are any hard limits for EscharEx in this setting beyond that 22.3% conversion estimate that you use. Josh JenningsAnalyst at TD Cowen00:35:47Barry, take this one as well. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:35:49Yeah. Yeah. Thanks. Listen, I think that there are still going to be situations, in particular, as I mentioned earlier, due to peripheral neuropathy in the diabetic foot ulcer segment, where it just might be easier for physicians to clean up a wound once or twice with a knife as opposed to several days of drug application. On the sharp side, it is the standard of care now. We do estimate taking around 10% of that of the utilization from sharp debridement, but there's still going to be a market for sharp debridement. This is not as one-to-one analogous as NexoBrid is with burns, where it can completely obviate the need for surgery. This is a little more soft in the chronic wound space. Again, that's why I say we estimate around 10% on the sharp side. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:36:51On the Autolytic side, it's just Autolytic debridement is so much less expensive that it depends on the setting, the case situation, the patient's insurance. There's still going to be a market for Autolytic debridement. Again, we believe that we're going to take a significant share from current Autolytic debridement. Right now, the legacy product relative to Autolytic debridement, you could look it up in the published literature, whether there's an advantage or not, but there's certainly a significant pricing differential, we believe, on that sort of ratio of price per clinical efficacy that we're going to hit a sweet spot and that it's going to encourage much more widespread adoption. There'll still be a market for it for Autolytic. Michael OkunewitchAnalyst at Maxim Group00:37:39Thank you. I really appreciate the additional insights. Once again, congrats on all the progress this quarter. Josh JenningsAnalyst at TD Cowen00:37:47Thank you, Michael. Operator00:37:51Ladies and gentlemen, with that, we will be ending today's question and answer session. I'd like to turn the floor back over to Ofer Gonen for closing remarks. Ofer GonenCEO at MediWound00:38:04Thank you, everyone, for joining us today, and we look forward to updating you again on our next quarterly call. Operator00:38:13With that, ladies and gentlemen, we will be concluding today's conference call. We do thank you for attending today's presentation. You may now disconnect your lines.Read moreParticipantsExecutivesBarry WolfensonEVP of Strategy and Corporate DevelopmentOfer GonenCEOHani LuxenburgCFOAnalystsMichael OkunewitchAnalyst at Maxim GroupJosh JenningsAnalyst at TD CowenDan FerryHead of Investor Relations at LifeSci AdvisorsAnalyst at H.C. Wainwright & CoJeff JonesAnalyst at OppenheimerPowered by