MDWD

Image source: The Motley Fool. Thursday, August 13, 2026 at 8:30 a.m. ET Chief Executive Officer - Ofer Gonen Chief Financial Officer - Hani Luxenburg Executive Vice President of Strategy and Corporate Development - Barry Wolfenson Operator: Good day, and welcome to the MediWound Second Quarter 2026 Earnings Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Gaia Shamis from LifeSci Advisors. Please go ahead. Gaia Shamis: Thank you, Chloe, and welcome, everyone. Earlier today, premarket opened, MediWound issued a press release announcing financial results for the second quarter ended June 30, 2026. You may access this press release on the company's website under the Investor 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. In 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 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; Hani Luxenburg, Chief Financial Officer; and Barry Wolfenson, Executive Vice President of Strategy and Corporate Development. Following our prepared remarks, we will open the call for Q&A. Now I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer? Ofer Gonen: Thank you, Gaia, and good morning, everyone. During the second quarter, we made meaningful progress against our strategic priorities, advancing EscharEx and [Technical Difficulty] Do you hear me? Operator: Yes, we can hear you. Please stand by while we reconnect our speaker connected our speaker. [Audio Gap] Pardon everyone we reconnected our speaker. Please proceed. Ofer Gonen: Okay. Sorry about that. So, thank you, Gaia, and good morning, everyone. During the second quarter, we made meaningful progress against our strategic priorities, advancing EscharEx and expanding the commercial and the development opportunities for NexoBrid. Specifically, the EscharEx global Phase III VLU trial is actively enrolling patients as our assessment of its addressable market continue to grow. For NexoBrid, Vericel reported its strongest quarter since launch, and we entered into a new master service agreement with Vericel following its BARDA contract. Now let's start with an update on EscharEx. The VALU study remains our top priority and our key long-term value driver. Our focus is on execution with enrollment ongoing, targeting the 216 patients across approximately 40 sites in the United States, Europe and Israel. As the study progresses, we are approaching two key milestones: first, the prespecified interim sample size reassessment and the second, completion of enrollment, both expected by the end of the first quarter of 2027. At the same time, we continue to build the broader commercial opportunity for EscharEx -- during this quarter, an independent global consulting firm completed an updated U.S. market assessment. Following the expansion of the analysis to include pressure ulcer, this updated assessment now estimates the U.S. annual peak sales at $1.05 billion. This analysis further strengthened our view that EscharEx across multiple chronic wound indications has the potential to address a substantial market opportunity. An investigator-initiated study evaluating EscharEx in pressure ulcers is expected to begin in the fourth quarter of 2026. Our collaboration network across the program now spans essentially all the major relevant advanced wound care companies, including Coloplast, ConvaTec, SD, Molnlycke, Solventum, B. Brown and MIMEDX. Together with the continued progress of the value and the expanding clinical and commercial opportunity, this positions EscharEx as a nonsurgical optimally effective debridement therapy for chronic wounds. Turning to NexoBrid. The U.S. commercial trajectory continues to strengthen. Vericel reported NexoBrid's strongest quarter since launch with record quarterly revenue, hospital unit sales and ordering centers. Approximately 80 burn centers have ordered NexoBrid since launch, reflecting continued adoption and increasing utilization across the U.S. burn care market. Following Vericel's 10-year contract with BARDA valued at up to $197 million, we entered into a master service agreement with Vericel covering NexoBrid and next-generation product development activities. Under the MSA, we expect to begin recognizing revenue in the second half of 2026 through participation in development initiatives, including a next-generation program launched to support the potential expansion of NexoBrid for use in blast and friction-related injuries, leveraging real-world evidence. We continue to advance a room temperature stable formulation of NexoBrid as a nonsurgical debridement solution for battlefield burn care, supported by nondilutive funding from the Department of War with a total program budget of $18.3 million. Together, these programs further expand NexoBrid growth, I'm here -- Together, this program further expands. Together, these programs further expand NexoBrid's role in burn care, national preparedness, military medicine and mass casualty response. To support current and future demand, we continue to advance our expanded NexoBrid manufacturing facility. We are implementing the modification requested by the EMA following the pre-audit and expect to complete this work during the fourth quarter of 2026. Commercial supply from the expanded facility remains subject to regulatory approval and is expected in the second half of 2027. With that, I will turn the call over to Hani. Hani Luxenburg: Thank you, Ofer, and good morning, everyone. Turning to our financial results for the second quarter of 2026. Revenue for the quarter was $3.1 million compared with $5.7 million in the second quarter of 2025. The decrease primarily reflected the timing of BARDA funded development revenue. Gross profit was $0.3 million, representing a gross margin of 10.9% compared with gross profit of $1.3 million or 23.5% in the prior year period. The lower margin primarily reflected a onetime impact related to the facility scale-up. Research and development expenses were $5.9 million compared with $3.5 million in the second quarter of 2025, primarily reflecting increased investment in the EscharEx value Phase III trial. SG&A expenses totaled $3.9 million compared with $3.6 million in the same period last year. Operating loss was $9.5 million compared with $5.7 million in the second quarter of 2025. Net loss was $7.4 million or $0.57 per share compared with a net loss of $13.3 million or $1.23 per share in the prior year period. The year-over-year change primarily reflected noncash financial income. Adjusted EBITDA loss was $8.3 million compared with a loss of $4.5 million in the second quarter of 2025. Turning to our first half results. Revenue for the first half of 2026 was $4.6 million compared with $9.7 million in the first half of 2025, primarily reflecting the timing of BARDA funded development revenue. Gross profit was $0.7 million, representing a gross margin of 14.4% compared with gross profit of $2.1 million or 21.5% in the prior year period. Research and development expenses were $11.1 million compared with $6.4 million in the first half of 2025, primarily reflecting increased investment in the EscharEx value Phase III trial. SG&A expenses totaled $7.5 million compared with $6.6 million in the same period last year. primarily reflecting higher professional services costs and exchange rate effects. Operating loss was $17.4 million compared with $10.9 million in the first half of 2025. Net loss was $10.3 million or $0.80 per share compared with a net loss of $14 million or $1.30 per share in the prior year period. The change primarily reflected noncash warrant revaluation income of $7.7 million in 2026 compared with a noncash warrant revaluation expense of $2.4 million in 2025. Adjusted EBITDA loss was $15.3 million compared with a loss of $8.5 million in the first half of 2025. Now turning to our balance sheet. As of June 2026, we had approximately $36 million in cash, cash equivalents and deposits compared with $54 million at year-end 2025. Cash burn during the first half of 2026 totaled $20 million. Warrants and option exercises generated $0.8 million during the first half, and we received an additional $1.1 million after quarter end. This concludes my review of our financial results. Ofer, back to you. Ofer Gonen: Thank you, Hani. The second quarter strengthened both our core growth platform. The value Phase III program of EscharEx continues to advance toward important milestones, while the updated market assessment and planned diabetic foot ulcer and pressure ulcer studies broaden its long-term clinical and commercial opportunity. NexoBrid continues to gain commercial traction in the United States. At the same time, the MSA with Vericel, the broader BARDA framework, the DOW funding, all that creates meaningful government-backed product supply and development opportunities. Our revenue profile remained weighted toward the second half of 2026, reflecting the expected timing of contributions from the MSA and other government-funded programs. Based on these expectation contributions, we are reaffirming our full year 2026 revenue guidance of $24 million to $26 million. Our priorities for the remainder of the year are clear: continue executing the VLU trial, begin recognizing revenue under the Vericel MSA, advance our next-generation NexoBrid programs and complete the EMA requested modification at our expanded manufacturing facility. We remain focused on disciplined execution across our strategic priorities and on building durable long-term value across our pipeline. Operator? Operator: [Operator Instructions] Our first question today comes from RK Ramakanth with H.C. Wainwright. Swayampakula Ramakanth: This is RK from H.C. Wainwright. Lots of stuff going on here. So, let's start off on the VLU study itself. On the study, do you still plan to get the study enrollment completed and get the interim also done during the early 2027? That's my first question. The second one within that is very recently, Smith & Nephew on their call, they were talking about potentially working on a second-generation SANTYL. Not sure you folks are aware of it. And what do you think -- what's your business intelligence on that molecule? And how does that impact EscharEx development from here onwards? Ofer Gonen: Excellent. So RK, thank you for joining. The first question is a short answer. Yes, our target of meeting the interim assessment and the enrollment completion is still in the first quarter of 2027. As for the second question regarding Smith & Nephew approach to potential competition from EscharEx, maybe, Barry, do you want to take this one? Barry Wolfenson: Sure. Absolutely. RK. We heard those comments, and we found them interesting. I think the thing that's most notable about the comments were the context where he was talking a little bit about -- someone asked him about the competition. He was talking a little bit about his thoughts around EscharEx. But then he said that they noted that sample is not a fast debridement option that it is slow. And because of this, that's what's driving their desire to make this second-generation product. It's actually being developed by a company that they've invested in called Certa Therapeutics. The molecule is SN or the drug, I should say, is SN-514. Based on all the publicly available information we've been able to see, we're not aware of this drug having entered into any clinical development in chronic wound patients. We see some activity around burns, but not chronic wounds. And so, while we take any potential competition seriously, EscharEx, as you know, is already in Phase III in chronic wounds, and that gives us what we believe to be a substantial clinical lead. Swayampakula Ramakanth: So now based on those comments, does that mean that the market is bigger than what it is because SANTYL is obviously not the molecule of choice if it is not really doing what it is expected to do? And then the second part of that is on the -- your team has added treasure ulcers into the pool now. So how is that study being conducted in the sense, what is your responsibility within that IIT and would that data be available by the time you're ready to file your own application with the agencies, both in the U.S. and in the -- with the EMA? Ofer Gonen: So Barry, maybe you will answer the first part of the question regarding Smith & Nephew and the market of pressure ulcer, and I'll speak about the study, okay? Barry Wolfenson: Yes. Well, I think even more broadly, what I think I heard you ask, RK, is does that mean that since SANTYL is not particularly effective and that Smith & Nephew is motivated to create a new drug, this must -- the inference is that the market is even bigger than what SANTYL is currently supplying. And we believe the answer to that is resoundingly yes. That's why as we -- even before including pressure ulcers, we showed our peak sales in the $800 million range. And with including pressure ulcers, it tops $1 billion. We believe that a drug for debridement that can reach complete debridement, certainly within four to five days changes the entire expectation with regard to enzymatic debridement. It fits better into the workflows of wound clinics and podiatry offices and it takes away because of that share -- utilization share, not just from sharp debridement, but across all different modalities. So, we do believe that it greatly expands the market. Ofer Gonen: So, if we speak about the pressure ulcer study, so it's important to mention that the Phase III VLU study in VLU -- this is the primary focus of EscharEx development program. It's, of course, the company's key value driver. The pressure ulcer study is an investigator initiated. So, it's not run directly by us. It's a small study, open-label trial, 10, 15 patients, and the initiation is expected in the fourth quarter of 2026. It enrolls, of course, pressure ulcer patients. All of them are treated with EscharEx across a week or 2. And we are assessing as usually debridement, granulation and wound closure. Following this -- the value readout, we plan to approach with the FDA and determine what would be required to pursue approvals also for DFU and pressure ulcers. Swayampakula Ramakanth: One last question. This is on NexoBrid. So, it's a two part question. The first one, what is EMA requesting you to do in terms of the new plant? And at least at the outset, it looks like time lines are moving back. So, is that true in your sense of the world? And also, if things get pushed to fourth quarter of '27, does that mean the real product for the market actually gets pushed into 2028? And the third part of the questions are on the CPT code, where do we stand? And is January 2027 still an effective and realistic date? Ofer Gonen: So I will address the manufacturing facility question. I think there was a confusion. As I said in the call, we completed the EMA pre-audit and the pre-audit process, and they recommended some operational changes that we are about to complete in the fourth quarter of this year, not the fourth quarter of 2027. So, we'll complete all the implementation this year. The feedback that we got was operational in nature, not related to product quality, safety or comparability concerns, which is very important. Once this work is complete, we will begin the manufacturing of NexoBrid in the new facility. And then following submission, review and inspection, we can get approval as early as in the second half of 2027. So, we have a delay. We reported this last quarter, but we are currently on track. As for your second question, the CPT code, Barry, do you want to address it? Barry Wolfenson: To my knowledge, there is no publicly available information regarding any update on a -- to a Category 1 CPT code. Operator: The next question comes from Josh Jennings with TD Cowen. Joshua Jennings: And Barry. I wanted to just touch on the updated MSA with Vericel. Can you just -- any additional details you can share just on the changes to revenue recognition? Is the major update that you'll be -- the recognizing of revenue for the development program that's been expanded for blast and friction injuries and potentially extending the shelf life of NexoBrid. And then the second question is just on the -- any updates to the path for the DFU indication in the clinical development program there. Ofer Gonen: Josh, good to speak to you. So let me speak about the BARDA economics and its strategic importance. So as mentioned, in April, Vericel was awarded a 10-year BARDA contract that is valued at up to $197 million. It is covering NexoBrid procurement, vendor-managed inventory, U.S.-based manufacturing readiness, next-generation formulation development and the potential blast and trauma expansion. It's a large. It's a multiyear framework agreement with several components. So, I understand the appetite for more precision. We are currently not in a position to share additional detail. It reflects confidentiality obligations to Vericel as well as the fact that several elements of the program remain subject to further FDA feedback, which could affect the scope of development and work required. What is concrete today is that the MSA is signed. The first development program, the blast injury, pain friction injuries is underway, and Vericel expects about $6 million of BARDA procurement revenue in the second half. Additional elements, including the room temperature stable formulation, the U.S.-based manufacturing readiness, -- these are areas that we are now in discussions with Vericel and BARDA regarding the scope, timing, technical requirements and potential implementation pathway. So, this is the maximum we can share right now. And as I said, we are about to begin recognizing revenue from that program in the second half of 2026. If this is good enough, I'm moving to the DFU? Okay. So, regarding the DFU, we have constructive discussions with the FDA and EMA. We got feedback. We are aligned on a DFU protocol. You can see the highlight of the protocol. It is attached to our corporate deck. And we plan to initiate the study in the fourth quarter of 2026. This Phase II DFU study is expected to enroll 50 patients. It's a randomized trial, 1:1 design, EscharEx versus placebo. And the primary endpoint is something that EscharEx is very good at time to complete debridement -- so we see it as a trial, which is not that complicated. As I said to the previous question that I asked by RK, we plan to approach the FDA after the value readout and then to determine what would be required to pursue approval for that indication as well. Operator: The next question comes from Jeff Jones with Oppenheimer. Jeffrey Jones: One point of clarification on the BARDA contract with Vericel. You noted that Vericel planning to receive $6 million in BARDA revenue in 2H. How then does that align with the $14 million to $15 million in BARDA revenue that you guys are projecting for 2026? Is that dependent on some of these other pieces that are on negotiation? And then in regards to NexoBrid, looking ahead into '26 and '27, how do we think about revenue given the facility now doesn't look to be coming online until 2H '27? Ofer Gonen: Okay. Jeff, good to have you on. So as for the first question, you gave there a number that I'm not familiar with, which is the 14. The 14 is not exclusively by BARDA. We have additional government-related agreements, one of them you are familiar with, which is the Department of War. So, expect some news there as well. The agreement with -- the MSA agreement with BARDA includes a few components. As I said, I cannot give you at this stage, used to confidentiality obligations, I cannot give you all the components. Having said that, the first program, which is development of blast and friction burn indication is on its way. Additional components are currently discussed and negotiated. As for the procurement, -- we -- MediWound expects to benefit from the procurement that BARDA is -- has with Vericel. It's not one-to-one. We have the transfer prices with Vericel. Nothing really is disclosed at this stage. But when you speak about the amount of development services, BARDA agreement, it contains a few components and not only one. Jeffrey Jones: Great. Ofer Gonen: This is the first sentence -- first question. As for the second question, Hani, do you want to address the manufacturing facility delay? Hani Luxenburg: Yes. Jeff, we do not actually expect the current facility timeline to have material impact on our 2026 revenue guidance. Importantly, a meaningful portion of the revenue we expect in the second half is associated, as you know, with government-funded development activity and product supply under existing agreements rather than being depending on commercial supply from our expanded facility. So, our $24 million to $26 million in 2026 revenue guidance already reflects the current status and the expected timing of our facility. Ofer Gonen: And as you asked also about '27 and '28, as I mentioned earlier about the facility readiness, we -- our plan is to finish all the modification by the end of the fourth quarter of this year. And first thing that we are going to do next year is to start manufacturing NexoBrid. So we don't think we have -- there will be any impact at all to the expected revenue in '27 and '28 for NexoBrid. Operator: The next question comes from Chase Knickerbocker with Craig-Hallum. Chase Knickerbocker: Maybe just on a little bit more specifics about value. Can you just talk about how the enrollment rate has trended sequentially on like a per site basis? And then can you just confirm that kind of all those 40 sites are up running and enrolling? And then just as we think about what your expectation for the 1Q resampling is, are you assuming any improvement in enrollment trends in that assumption? Or is it just kind of static? Ofer Gonen: Chase, good to have you with us. As for the value, let's speak about the numbers to protect the integrity of the study, we cannot share patient enrollment numbers or enrollment trends during the conduct of the study in a multinational study, individual snapshot can be noisy and the advice we are getting is not to share any information. We think the more useful commitment is the milestones. It's the interim assessment and the enrollment completion. What can I say now is that the design hasn't changed, 216 patients, roughly 40 sites, and we expect the interim sample size reassessment and enrollment completion to be by the end of the first quarter of 2027. We do not need any improvement or changes in trends. We are on track. I hope I answered the first question, right? Chase Knickerbocker: Yes. And maybe you can -- I mean, you've spoken to kind of active sites in the past. Can you maybe just speak to kind of the update there? -- Go ahead. Ofer Gonen: Regarding the sites, as we said, we are targeting approximately 40 sites, and we are something like very close to have them all recruiting. It's -- we have more -- less than 10% to reach this target. Chase Knickerbocker: Got it. And then maybe just as we think about -- you obviously are also guiding to full enrollment, but if we just think about top line data kind of post last patient enrolled, I mean, should we think about it as kind of 12 weeks, obviously, to that wound healing follow-up and then kind of a month or two for data lock and the like? Or maybe just talk us through exactly how that time line will work? And then lastly, just one for Barry. So, we're seeing a pretty large volume shift in wound care from Site 11 to Site 22. Can you just remind us the sites of service that you think EscharEx will predominantly be used in if approved? And then if you could just remind us again where kind of SANTYL usage is concentrated today and how you expect that to kind of change from a mix perspective for EscharEx? Ofer Gonen: So, Barry, let me start with answering about the clinical trial, if this is okay. Well, you got it quite accurately, Chase. Our plan is to have the interim assessment by the end of Q1. If everything goes well, it takes another quarter or so to get the top line data. And after the top line data, it is another few months until the final results. As for EscharEx, Barry, do you want to address it? Barry Wolfenson: Sure. Most of that shifting, of course, Chase, has to do with the CMS change to how it reimburses the tissue substitute products. Based on the third-party data that we've acquired regarding prescriptions of SANTYL, it's fairly well distributed across acute care into clinics, into home health and certainly into nursing homes and SNFs. And we don't see that materially changing nor do we see that being any different for EscharEx. Operator: The next question comes from Michael Okunewitch with Maxim Group. Michael Okunewitch: So, I just -- I wanted to follow up on the question surrounding the '27 revenues and particularly to understand mechanically how that works with your current projections. since it's nearly a doubling of the NexoBrid specific revenues that you are projecting. So, is this a case where there's pent-up demand that would lead to a surge in sales in the fourth quarter once you get that approval? Or can you actually ship the product and recognize revenue before the second half EMA commissioning? Ofer Gonen: Michael, this is a good question. So, as I said, we are actually manufacturing the NexoBrid in the beginning of 2027. Everything is ready to be shipped. The demand is there. Second half of 2027, we can sell significantly more than we are selling now. Currently, as you know, our ability to sell is capped by manufacturing capabilities. And in 2027, this limitation will finally be removed. Michael Okunewitch: All right. And then what is the delay on the EMA side effect FDA? Is that still one half after EMA approval? Or would these now be contemporaneous? Ofer Gonen: Mathematically, it's something like three months. Having said that, the most important milestone is getting the first approval. As I mentioned in the previous call, and I'm sure that you remember, EMA comes first. And once EMA come first, we can start selling substantially most of the inventory to the European countries. And then the current facility can be dedicated to sell to the U.S. market and to stockpile for governments. So, this is the more important milestone. So, this is why we are speaking about the first regulatory approval. If FDA happens three months after that or five months after that depends on inspections and other things, I don't think it will really change anything for a revenue point of view. Michael Okunewitch: And then one last one for me before I hop back into the queue. In the second half of this year, you are expecting quite a significant uptick in revenues, particularly from development services, well beyond what you've seen historically even when you had the full BARDA contract up and running. So, I wanted to understand what's going to be driving that? Is that primarily the new programs that have been announced taking effect? Or is there some front-loading to the new BARDA contract you signed after the lapse? Ofer Gonen: So yes, you're right. We are reaffirming the $24 million to $26 million revenue guidance for 2026. Since the revenue for the first half was $4.6 million. Clearly, the majority of the year -- it is weighted towards the second half of the year. We expect meaningful step-up in H2, driven by the product supply related to the contracts, development services under the Vericel MSA and other government-funded programs, including the Department of War and of course, the ongoing commercial NexoBrid sale. Under the MSA, we just announced that we initiated the first development program to support the expansion to last injuries. But we -- as I mentioned, we expect to initiate additional development programs under the MSA in the near term as well. Operator: The next question comes from Scott Henry with Alliance Global Partners. Scott Henry: Most of my questions have been asked, but I did want to follow up on the product sales for 2026. Obviously, the $2.6 million was very strong in 2Q, but first quarter was only $528,000 based on what I got out of the filings. Would it be better to think about capacity for product sales as kind of the combination of those 2, so about $1.7 million to $1.8 million per quarter. Is that kind of how much you can make in a quarter until we get this capacity? Is that how I should be thinking about it? Or could you duplicate $2.6 million again prior to the capacity expansion? Ofer Gonen: Scott, as you know, we are not guiding specifically for product, but I don't think it will be the right thing to do is to think that we sold everything that we could. Again, we are capped only by capacity, not by demand. The inventory of NexoBrid is currently zero, I think, in most territories and definitely here in the facility. Some of the impacts that we -- that you saw that prevented us from to generate more revenue were because of the fact that the facility itself needed to go through all kind of inspections and all kind of upgrades, et cetera. So, I think it would be more accurate to look at the second quarter. Having said that, I would look at last year, and we are selling everything that we have. So maybe last year, if you add, let's say, 10% premium because of price changes and a little bit more effectiveness, I think it will be more accurate. Scott Henry: Okay. Thanks for the color. That is helpful. And then perhaps a question for Hani. R&D, should we expect a significant spike still in the second half of '26. How should we think about the next couple of quarters there? Ofer Gonen: Scott, the increase in R&D is, as you know, primarily driven by our VALUE Phase III trial, which remain our top strategic priority in the company. We are not providing quarterly R&D, but we -- guidance, but we currently at an elevated level of investment and expect R&D spending to remain elevated as value progresses through this phase of our program. At the same time, a meaningful portion of our NexoBrid development activity is supported, as you know, by nondilutive government funding through BARDA and through the Department of War. So, while we are investing significantly in value, we are also being very disciplined about where we deploy our own capital. I hope I answered your question. Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Ofer Gonen for any closing remarks. Ofer Gonen: So thank you, everyone, for joining us today. We look forward to updating you again on our next quarterly call. Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Before you buy stock in MediWound, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and MediWound wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. The EscharEx Phase III VALU study remains the primary value driver, with enrollment active across approximately 40 sites in the U.S., Europe, and Israel. Updated U.S. market assessments for EscharEx now estimate peak annual sales at $1.05 billion, following the inclusion of pressure ulcers in the addressable market analysis. NexoBrid achieved record quarterly revenue and hospital adoption in the U.S., though total revenue decreased year-over-year due to the timing of BARDA-funded development cycles. Management entered a new Master Service Agreement (MSA) with Vericel to leverage a 10-year, $197 million BARDA contract for next-generation product development. Gross margins were temporarily impacted by a one-time facility scale-up cost, while R&D expenses rose to support the accelerated Phase III clinical activity. Strategic positioning for NexoBrid is shifting toward national preparedness and military medicine, supported by $18.3 million in Department of War funding for room-temperature stable formulations. Reaffirmed full-year 2026 revenue guidance of $24 million to $26 million, with performance heavily weighted toward the second half due to MSA contributions and government programs. Targeting the completion of both the prespecified interim sample size reassessment and full patient enrollment for the VALU study by the end of Q1 2027. Expect to begin recognizing revenue from the Vericel MSA in the second half of 2026, specifically through initiatives for blast and friction-related injury expansion. Manufacturing modifications requested by the EMA are expected to be completed in Q4 2026, with commercial supply from the expanded facility projected for the second half of 2027. Planned initiation of a Phase II diabetic foot ulcer (DFU) study and an investigator-initiated pressure ulcer study in Q4 2026 to broaden the EscharEx label. EMA pre-audit feedback necessitated operational modifications at the new manufacturing facility; management clarified these are not related to product quality or safety. Current NexoBrid commercial supply is capped by existing manufacturing capacity, with inventory levels at zero in most territories until the new facility is approved. Non-cash financial income, including a $7.7 million warrant revaluation, significantly narrowed the reported net loss despite higher operating expenses. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management noted that Smith & Nephew's pursuit of a faster debridement option validates the market need for EscharEx's rapid efficacy. EscharEx maintains a substantial clinical lead as the competitor molecule (SN-514) has not yet entered clinical development for chronic wounds. Management expects no material impact on 2027 revenue because they will begin manufacturing at risk in early 2027 to build inventory ahead of the H2 approval. The first regulatory approval (expected from EMA) will allow the new facility to serve Europe while the legacy facility focuses on U.S. demand. The projected revenue spike is driven by a combination of product supply, new development services under the Vericel MSA, and Department of War programs. Management noted that while Vericel expects $6 million in BARDA procurement, MediWound's benefit includes transfer pricing and multiple development service components.

Interested in MediWound Ltd.? Here are five stocks we like better. EscharEx development advanced: MediWound is enrolling its global Phase III VALUE trial, targeting completion and interim sample-size reassessment by the end of Q1 2027. An expanded U.S. market assessment estimates peak annual sales potential of $1.05 billion, including pressure ulcers. NexoBrid adoption and government programs grew: Vericel reported record quarterly NexoBrid revenue, hospital unit sales and ordering centers, with about 80 burn centers having ordered the product. MediWound expects revenue from its up-to-$197 million BARDA-related agreement to begin in the second half of 2026. Financial performance weakened amid higher investment: Q2 revenue fell to $3.1 million from $5.7 million, while R&D expense rose to $5.9 million and the operating loss widened to $9.5 million. The company ended June with about $36 million in cash and reaffirmed 2026 revenue guidance of $24 million to $26 million. MediWound (NASDAQ:MDWD) reported second-quarter 2026 revenue of $3.1 million, down from $5.7 million a year earlier, as the company continued investing in its Phase III EscharEx chronic-wound program and expanded development work around its NexoBrid burn treatment. Chief Executive Officer Ofer Gonen said the company’s top priority remains the global Phase III VALUE trial of EscharEx. The study is enrolling patients at sites in the United States, Europe and Israel, with a target of 216 patients across approximately 40 sites. MediWound expects both the trial’s pre-specified interim sample-size reassessment and enrollment completion by the end of the first quarter of 2027. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Gonen said an updated U.S. market assessment conducted by an independent global consulting firm estimated annual peak sales potential for EscharEx at $1.05 billion after adding pressure ulcers to the analysis. MediWound had previously cited an approximately $800 million peak-sales opportunity before including pressure ulcers, according to comments from Executive Vice President of Strategy and Corporate Development Barry Wolfenson during the question-and-answer session. EscharEx is being developed as a non-surgical debridement therapy for chronic wounds. The company said an investigator-initiated, open-label pressure-ulcer study involving approximately 10 to 15 patients is expected to begin in the fourth quarter of 2026. The study will evaluate measures including debridement, granulation and wound closure. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand MediWound also plans to initiate a Phase II diabetic foot ulcer, or DFU, trial in the fourth quarter. Gonen said the company has received feedback from the FDA and European Medicines Agency and is aligned on the protocol. The randomized study is expected to enroll 50 patients and compare EscharEx with placebo, using time to complete debridement as its primary endpoint. Following the VALUE trial readout, MediWound plans to discuss with regulators what would be needed to pursue approvals for diabetic foot ulcers and pressure ulcers, Gonen said. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Wolfenson addressed comments from Smith & Nephew regarding a potential second-generation SANTYL product. He said MediWound was aware of the remarks and noted that, based on publicly available information, the product under development by Certa Therapeutics, SN514, had not entered clinical development in chronic-wound patients. Wolfenson said EscharEx’s Phase III status in chronic wounds provides what the company believes is a substantial clinical lead. For NexoBrid, MediWound said U.S. commercial momentum continued to build through its commercial partner, Vericel. Gonen said Vericel reported NexoBrid’s strongest quarter since launch, including record quarterly revenue, hospital unit sales and ordering centers. Approximately 80 burn centers have ordered NexoBrid since its launch, he said. MediWound and Vericel entered a master service agreement following Vericel’s 10-year BARDA contract, which is valued at up to $197 million. The BARDA framework covers NexoBrid procurement, vendor-managed inventory, U.S.-based manufacturing readiness, next-generation formulation development and potential expansion into blast and trauma-related injuries, Gonen said. The first development program under the agreement, aimed at supporting potential NexoBrid use in blast and friction injuries, is underway. MediWound expects to begin recognizing revenue from the master service agreement during the second half of 2026. Gonen said Vericel expects approximately $6 million in BARDA procurement revenue in the second half, while declining to provide further details on the broader agreement because of confidentiality obligations and pending regulatory feedback. The company is also developing a room-temperature stable NexoBrid formulation for battlefield burn care with non-dilutive funding from the Department of War. The total program budget is $18.3 million. MediWound is completing modifications requested by the EMA after a pre-audit of its expanded NexoBrid manufacturing facility. Gonen said the requested changes were operational and were not related to product quality, safety or comparability. The company expects to finish the work in the fourth quarter of 2026, begin manufacturing at the facility in early 2027 and potentially receive regulatory approval for commercial supply in the second half of 2027. Management said the revised facility timing is not expected to materially affect 2026 guidance or anticipated NexoBrid revenue in 2027 and 2028. The company said current NexoBrid sales are constrained by manufacturing capacity rather than demand. Second-quarter revenue was $3.1 million, compared with $5.7 million in the prior-year quarter, primarily due to the timing of BARDA-funded development revenue. Gross profit was $0.3 million, with a 10.9% gross margin, compared with $1.3 million and a 23.5% margin a year earlier. The company cited a one-time facility scale-up impact. Research and development expense rose to $5.9 million from $3.5 million, reflecting increased investment in the EscharEx VALUE trial. Operating loss was $9.5 million, compared with $5.7 million a year earlier. Net loss was $7.4 million, or $0.57 per share, compared with net loss of $13.3 million, or $1.23 per share, in the prior-year period. The change reflected non-cash financial income. For the first half, MediWound reported revenue of $4.6 million, down from $9.7 million a year earlier, and an adjusted EBITDA loss of $15.3 million, compared with an $8.5 million loss in the prior-year period. As of June 30, the company had approximately $36 million in cash, cash equivalents and deposits, down from $54 million at year-end 2025. First-half cash burn totaled $20 million. MediWound reaffirmed its full-year 2026 revenue guidance of $24 million to $26 million. Gonen said revenue is expected to be weighted toward the second half, supported by product supply, development services under the Vericel agreement, other government-funded programs and ongoing NexoBrid commercial sales. MediWound Ltd. (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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "MediWound Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. MediWound Ltd (NASDAQ:MDWD) reaffirmed its full-year 2026 revenue guidance of $24 million to $26 million, with a revenue profile weighted toward the second half of the year. The EscharEx Phase 3 VALUE trial is on track, with interim sample size reassessment and enrollment completion expected by the end of Q1 2027, and the company is close to having all ~40 sites recruiting. Updated U.S. market assessment for EscharEx, now including pressure ulcers, estimates annual peak sales at $1.05 billion, expanding the commercial opportunity. NexoBrid achieved its strongest quarter since launch, with record quarterly revenue, hospital unit sales, and ordering centers, and approximately 80 burn centers have ordered the product. The new master service agreement with VeriCell, following the BARDA contract, is expected to generate revenue in H2 2026, and the company is advancing a room-temperature stable formulation funded by the Department of War. The company has a broad collaboration network with major advanced wound care companies, positioning EscharEx as a leading non-surgical debridement therapy. Q2 2026 revenue declined to $3.1 million from $5.7 million in Q2 2025, primarily due to the timing of BARDA-funded development revenue. Gross margin fell to 10.9% from 23.5% in the prior year period, impacted by a one-time facility scale-up cost. Operating loss widened to $9.5 million in Q2 2026 from $5.7 million in Q2 2025, driven by increased R&D investment in the VALUE trial. Cash burn was $20 million in the first half of 2026, reducing cash to $36 million from $54 million at year-end 2025. The expanded manufacturing facility for NexoBrid is delayed, with commercial supply now expected in the second half of 2027, subject to regulatory approval. The company faces potential competition from Smith & Nephew's second-generation Santyl product, though it is not yet in clinical development for chronic wounds. Warning! GuruFocus has detected 7 Warning Signs with MDWD. Is MDWD fairly valued? Test your thesis with our free DCF calculator. Q: Regarding the EscharEx VALUE Phase 3 study, do you still plan to complete enrollment and the interim analysis by early 2027? Also, what is your business intelligence on Smith & Nephew's potential second-generation Santyl product, and how does it impact EscharEx development? A: CEO Ofer Gonen confirmed that the target for both the interim sample size reassessment and enrollment completion remains the end of the first quarter of 2027. EVP of Strategy and Corporate Development Barry Wolfson addressed the competitive threat, noting that Smith & Nephew's comments confirm Santyl is not a fast debridement option, which is why they are developing a second-generation product (SN514) via Certa Therapeutics. However, this drug has not entered clinical development for chronic wounds, whereas EscharEx is already in Phase 3, giving it a substantial clinical lead. Q: Can you provide more details on the updated Master Service Agreement (MSA) with Vericel, specifically regarding revenue recognition and the expansion into blast and friction injuries? Also, what is the latest on the DFU clinical development path? A: CEO Ofer Gonen explained that the MSA follows Vericel's 10-year BARDA contract (up to $197 million) and covers NexoBrid procurement, vendor-managed inventory, US-based manufacturing readiness, and next-generation formulation development. While confidentiality limits full disclosure, the first development program for blast and friction injuries is underway, and revenue recognition will begin in H2 2026. Regarding DFU, the company has aligned with the FDA and EMA on a Phase 2 protocol, which will enroll 50 patients in a 1:1 randomized trial versus placebo, with the primary endpoint of time to complete debridement. The study is expected to initiate in Q4 2026. Q: Regarding the BARDA contract with Vericel, how does the $6 million in BARDA revenue Vericel expects in H2 align with the $14-15 million in BARDA revenue you are projecting for 2026? Also, how should we think about NexoBrid revenue in 2026 and 2027 given the facility delay? A: CEO Ofer Gonen clarified that the $14 million figure is not exclusively from BARDA, as it includes other government agreements like the Department of War. The BARDA MSA includes several components, and the first development program is underway, with additional components under negotiation. CFO Hani Luxenberg added that the facility timeline will not materially impact 2026 revenue guidance, as a significant portion of H2 revenue comes from government-funded development activity and product supply under existing agreements, not commercial supply from the expanded facility. The company expects no impact on 2027-2028 NexoBrid revenue. Q: Can you provide specifics on the VALUE trial enrollment rate per site and confirm if all 40 sites are actively enrolling? Also, does your expectation for the Q1 resampling assume any improvement in enrollment trends? A: CEO Ofer Gonen stated that to protect the integrity of the study, the company cannot disclose patient enrollment numbers or trends during the conduct of the multinational study. He reiterated that the design remains unchanged (216 patients, ~40 sites) and that the interim assessment and enrollment completion are expected by the end of Q1 2027. He confirmed the company is on track and does not require any improvements in enrollment trends. Regarding sites, he noted they are very close to having all ~40 sites recruiting, with less than 10% remaining to reach the target. Q: What is the EMA requesting regarding the expanded manufacturing facility, and has the timeline slipped? Does this push product availability to 2028? Also, what is the status of the CPT code, and is January 2027 still realistic? A: CEO Ofer Gonen clarified that the EMA pre-audit recommended operational changes, not related to product quality, safety, or comparability. These modifications will be completed in Q4 2026 (not 2027). After completion, manufacturing will begin, with regulatory approval expected as early as H2 2027. He acknowledged a delay but confirmed the company is on track. EVP Barry Wolfson stated there is no publicly available information regarding an update to a Category 1 CPT code. Q: Given the strong Q2 product sales of $2.6 million versus $528,000 in Q1, should we think about capacity as roughly $1.7-1.8 million per quarter until the capacity expansion? Can you duplicate the $2.6 million quarter? A: CEO Ofer Gonen explained that the company is capped by capacity, not demand, and inventory is currently zero. He suggested that Q2 is a more accurate reflection of run-rate, but noted that last year's sales plus a ~10% premium for price changes and effectiveness would be a more accurate baseline. He did not provide specific quarterly guidance but indicated the company is selling everything it produces. Q: Should we expect a significant spike in R&D spending in H2 2026, and how should we model the next couple of quarters? A: CFO Hani Luxenberg stated that the increase in R&D is primarily driven by the VALUE Phase 3 trial, which remains the top strategic priority. While not providing quarterly guidance, he confirmed that R&D spending will remain elevated as the trial progresses. However, a meaningful portion of NexoBrid development activity is supported by non-dilutive government funding through BARDA and the Department of War, allowing the company to be disciplined in deploying its own capital. Q: Regarding the pressure ulcer study, how is it being conducted, what is MediWound's responsibility, and will the data be available by the time you file with the FDA and EMA? A: CEO Ofer Gonen explained that the pressure ulcer study is an investigator-initiated initiative, not run directly by the company. It is a small, open-label trial of 10-15 patients expected to initiate in Q4 2026. Patients will be treated with EscharEx over one to two weeks, assessing debridement, correlation, and wound closure. Following the VALUE readout, the company plans to approach the FDA to determine requirements for pursuing approvals for DFU and pressure ulcer indications. Q: Given Smith & Nephew's comments about Santyl's limitations, does this imply the market is larger than currently estimated? Also, where do you see EscharEx being used if approved, and where is Santyl usage concentrated today? A: EVP Barry Wolfson confirmed that the market is indeed larger than For the complete transcript of the earnings call, please refer to the full earnings call transcript.

EscharEx® Phase III VALUE Trial Advancing; Interim Assessment and Enrollment Completion Expected by End of First Quarter 2027 Master Services Agreement Signed with Vericel Under its BARDA Contract for NexoBrid® Second Quarter Revenue of $3.1 Million; Full-Year 2026 Revenue Guidance of $24–26 Million Reaffirmed Conference Call Today at 8:30 a.m. Eastern Time YAVNE, Israel, Aug. 13, 2026 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update. “In the second quarter, we continued to make meaningful progress with our two key programs,” said Ofer Gonen, Chief Executive Officer of MediWound. “The EscharEx Phase III VALUE trial is advancing across the U.S., Europe, and Israel, with the interim sample size reassessment and completion of enrollment expected by the end of the first quarter of 2027. For NexoBrid, we strengthened the commercial opportunity through our new agreement with Vericel under its BARDA contract, which is expected to contribute to revenue in the second half of 2026.” Second Quarter 2026 Highlights, Recent Developments, and Upcoming Milestones EscharEx® Enrollment continues in the global Phase III VALUE trial in venous leg ulcers (VLUs), targeting 216 patients across approximately 40 sites in the U.S., Europe, and Israel. The pre-specified interim sample size reassessment and completion of enrollment are expected by the end of the first quarter of 2027. An updated U.S. market assessment by an independent global consulting firm estimates U.S. annual peak sales potential for EscharEx at $1.05 billion, following expansion of the assessment to include pressure ulcers (PUs). An investigator-initiated trial evaluating EscharEx in PUs is expected to begin in the fourth quarter of 2026. NexoBrid® Vericel reported NexoBrid’s strongest quarter since launch, with record quarterly revenue, hospital unit sales and ordering centers. Approximately 80 burn centers have ordered NexoBrid since launch, reflecting continued adoption and increasing utilization across the U.S. burn care market. Following Vericel’s 10-year contract with BARDA, valued at up to $197 million (the “BARDA Contract”), the Company and Vericel entered into a Master Services Agreement (the “MSA”) covering NexoBrid and next-generation product development activities. Under the MSA, the Company expects to begin recognizing revenue in the second half of 2026 by participating in a next generation development program that has been initiated to support the potential expansion of NexoBrid for use in blast- and friction-related injuries, leveraging real-world evidence. EMA-requested modifications are being implemented following the pre-audit of the expanded NexoBrid manufacturing facility, with completion expected in the fourth quarter of 2026. Commercial supply from the expanded facility remains subject to regulatory approval and is expected in the second half of 2027. 2026 Revenue Guidance The Company reaffirmed its full-year 2026 revenue guidance of $24–26 million, supported by expected second-half contributions from the MSA and other government-funded programs. Second Quarter 2026 Financial Highlights Revenue was $3.1 million, compared with $5.7 million in the second quarter of 2025, primarily reflecting the timing of BARDA-funded development revenue. Gross profit was $0.3 million, or 10.9% of revenue, compared with $1.3 million, or 23.5% of revenue, in the prior-year period. The decrease primarily reflected a one-time impact related to the facility scale-up. Research and development expenses were $5.9 million, compared with $3.5 million, primarily reflecting increased investment in the EscharEx Phase III VALUE trial. Selling, general and administrative expenses were $3.9 million, compared with $3.6 million. Operating loss was $9.5 million, compared with $5.7 million. Net loss was $7.4 million, or $0.57 per share, compared with $13.3 million, or $1.23 per share, primarily reflecting non-cash financial income. Adjusted EBITDA loss was $8.3 million, compared with $4.5 million. First Half 2026 Financial Highlights Revenue was $4.6 million, compared with $9.7 million in the first half of 2025, primarily reflecting the timing of BARDA-funded development revenue. Gross profit was $0.7 million, or 14.4% of revenue, compared with $2.1 million, or 21.5% of revenue. Research and development expenses were $11.1 million, compared with $6.4 million, primarily reflecting increased investment in the EscharEx Phase III VALUE trial. Selling, general and administrative expenses were $7.5 million, compared with $6.6 million, primarily reflecting higher professional services costs and exchange-rate effects. Operating loss was $17.4 million, compared with $10.9 million. Net loss was $10.3 million, or $0.80 per share, compared with $14.0 million, or $1.30 per share. The change primarily reflected non-cash warrant revaluation income of $7.7 million in 2026, compared with an expense of $2.4 million in 2025. Adjusted EBITDA loss was $15.3 million, compared with $8.5 million. Balance Sheet and Other Highlights As of June 30, 2026, cash, cash equivalents and deposits totaled $36 million, compared with $54 million at year-end 2025. Cash burn during the first half of 2026 totaled $20 million. Warrant and option exercises generated $0.8 million during the period and an additional $1.1 million after quarter-end. Conference Call and Webcast MediWound management will host a conference call for investors on Thursday, August 13, 2026, beginning at 8:30 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may join the conference call by dialing 1-844-676-8833 (in the U.S.), 1-809-212373 (Israel), or 1-412-634-6869 (outside the U.S. & Israel). The call will be available via webcast by clicking HERE or on the Events & Presentations page of the Company’s website. A replay of the call will be available on the Company’s website at www.mediwound.com. Non-IFRS Financial Measures To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company’s performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, certain non-recurring expenses, restructuring and share-based compensation expenses. Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management. However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company’s operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below. About MediWound MediWound Ltd. (Nasdaq: MDWD) is a global biotechnology company pioneering enzymatic, non-surgical therapies for tissue repair. The company’s FDA-approved biologic, NexoBrid®, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the United States, the European Union, Japan, and additional international markets. MediWound’s late-stage pipeline product, EscharEx®, is an investigational therapy for the debridement of chronic wounds, with the potential to become, if approved, a new standard of care in wound management. For more information, visit www.mediwound.com and follow us on LinkedIn and X (formerly Twitter). Cautionary Note Regarding Forward-Looking Statements MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions. Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives, anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx® and NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; our contracts with governmental agencies; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and product candidates; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; geopolitical risks, including armed conflict, the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future. These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 5, 2026 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound does not undertake, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

United Therapeutics (UTHR) came out with quarterly earnings of $7.27 per share, beating the Zacks Consensus Estimate of $6.82 per share. This compares to earnings of $6.41 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +6.60%. A quarter ago, it was expected that this drugmaker would post earnings of $6.73 per share when it actually produced earnings of $5.82, delivering a surprise of -13.52%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. United Therapeutics, which belongs to the Zacks Medical - Drugs industry, posted revenues of $783.3 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 2.51%. This compares to year-ago revenues of $798.6 million. The company has not been able to beat consensus revenue estimates over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. United Therapeutics shares have added about 6.5% since the beginning of the year versus the S&P 500's gain of 13%. While United Therapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for United Therapeutics was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $7.03 on $819.4 million in revenues for the coming quarter and $26.65 on $3.23 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. MediWound (MDWD), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 13. This developer of treatments for burns and hard-to-heal wounds is expected to post quarterly loss of $0.76 per share in its upcoming report, which represents a year-over-year change of +38.2%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. MediWound's revenues are expected to be $2.59 million, down 54.7% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report United Therapeutics Corporation (UTHR) : Free Stock Analysis Report MediWound Ltd. (MDWD) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. The EscharEx Phase III VALUE study timeline shifted by one quarter due to ancillary-related regulatory adjustments at European sites and logistical challenges for elderly patients. Management implemented patient assistance measures, including transportation and hotel reimbursements, to mitigate participation burdens associated with daily wound assessment protocols. The protocol's requirement for daily assessments, while operationally complex, is intended to capture EscharEx's rapid debridement speed as a key clinical differentiator. Collaboration network expanded to include Medline, meaning essentially all major advanced wound care companies are now engaged with the EscharEx program. NexoBrid adoption continues to grow in the U.S. burn care market, supported by a new 10-year BARDA contract valued at up to $197 million for procurement and development. Manufacturing expansion is undergoing operational modifications following an EMA pre-audit, with implementation activities expected to conclude in the second half of 2026. Q1 revenue decline was primarily driven by the timing of BARDA-related revenue and postponed shipments resulting from regional conflict. Full-year 2026 revenue guidance of $24 million to $26 million is reaffirmed, with performance heavily weighted toward the second half of the year. Interim sample size reassessment and enrollment completion for the VALUE study are now projected for the end of the first quarter of 2027. BARDA-related procurement and development activities are expected to commence during the second half of 2026. Phase II studies for EscharEx in diabetic foot ulcers and pressure ulcers are scheduled to begin in the second half of 2026. FDA inspection of the expanded manufacturing facility is planned for early 2027, contingent upon finalizing EMA operational modifications in late 2026. Regional conflict caused temporary shipment postponements in Q1, though management confirmed these shipments have since been completed. Recent CMS reimbursement changes for skin substitutes are expected to reduce that market segment by 90%, potentially increasing the relative value of EscharEx as a non-surgical alternative. The EMA pre-audit identified operational modifications required for the new facility; management noted these do not relate to product quality, safety, or comparability. Foreign exchange movements between the U.S. dollar and Israeli shekel impacted net cash used in operating activities during the quarter. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management stated that slower recruitment was due to operational factors, not safety or efficacy concerns, and that 40 active sites will be reached within weeks. The company is prioritizing the 'right' patients over speed to ensure study results can replicate previous successful data. The feedback was strictly operational and does not affect product comparability or safety. Management expects to complete implementation in the second half of 2026 and does not anticipate risks to 2026 revenue guidance from these changes. Medline will provide its Marathon skin protectant for the DFU Phase II study to protect periwound tissue during debridement. These collaborations allow MediWound to standardize the control arm of studies and build relationships with potential future commercial partners. Second-half revenue will be driven by government-related development services and burn mass casualty preparedness activities. The $197 million BARDA contract includes five components, including procurement and next-generation formulation, with revenue starting in the second half of 2026.

Image source: The Motley Fool. Wednesday, May 27, 2026 at 8:30 a.m. ET Chief Executive Officer — Ofer Gonen Chief Financial Officer — Hani Luxenburg Chief Strategy and Corporate Development Officer — Barry Wolfenson Ofer Gonen: Thank you, Dan, and good morning, everyone. During the first quarter of 2026, we continue to execute against our key strategic priorities, advancing EscharEx towards commercialization and expanding the global role of NexoBrid. While the timeline for EscharEx Phase III VALUE study has shifted by 1 quarter, the underlying momentum behind the program continues to strengthen. During this quarter, we expanded our chronic wound collaboration network, generated additional clinical and scientific validation for both EscharEx and NexoBrid and continue to see strong engagement from strategic collaborators and the broader wound care community. We continue to advance our expanded NexoBrid manufacturing facility towards commercial readiness and further strengthen long-term opportunities with industry leaders and government partners across our portfolio. Let me start with an update on EscharEx. Enrollment continues in the global Phase III VALUE study in venous leg ulcers with more than 30 sites active across the United States, Europe and Israel. Recruitment has progressed more gradually than originally anticipated, primarily due to 2 operational factors. First, certain European sites required ancillary-related regulatory adjustments, which have been now completed, and we expect the study to reach the targeted 40 active sites within weeks. Second, the travel and visit requirements associated with the protocol created participation challenges for the older and medically complex VLU patient population. To support enrollment and reduce participation burden, we implemented patient assistance measures, including hotel reimbursements, transportation services and facilitated access to enhanced care. Importantly, given how quickly EscharEx works, the protocol requires daily wound assessment to determine the exact day complete debridement is achieved. This represents a shift from measuring debridement outcomes over weeks. While this creates operational complexity in the study, it may ultimately reflect one of EscharEx's key clinical and commercial advantages in real-world practice. Investigator engagement and site participation remains strong across all regions, and we expect the interim sample size reassessment and the enrollment completion by the end of the first quarter of 2027. At the same time, we continue to see expanding commercial, clinical and scientific validation supporting the broader opportunity of EscharEx across the chronic wound care market. Medline, a global leader in medical surgical and wound care products, has joined our collaboration network. Together with Coloplast/Kerecis, Convatec, Essity, Mölnlycke, Solventum, B. Braun and MIMEDX, our collaborators now include essentially all the major advanced wound care companies relevant to the program. As part of the collaboration, Medline will provide its class-leading skin protectant, Marathon, for the upcoming DFU Phase II study. Marathon is designed to protect tissue surrounding the wound, while EscharEx performed its debridement activity within the wound bed. A peer-reviewed U.S. expert consensus document published in Wound Journal emphasized the need for effective, easy-to-use and less invasive debridement approaches in chronic wound care, a conclusion that aligns closely with the clinical profile and positioning of EscharEx. We also presented new clinical data and new preclinical data at the WHS, SAWC and EWMA conferences, highlighting EscharEx's clinical benefits, distinct mechanism of action and broad potential across venous leg ulcers, diabetic foot ulcers and pressure ulcers. Turning to NexoBrid. During the quarter, we continue to see growing commercial adoption, clinical recognition and strategic interest in NexoBrid across both traditional burn care settings and government preparedness initiatives. Vericel reported continued growth in both ordering centers and total orders across the United States burn care market, reflecting ongoing adoption trends. Most importantly, Vericel was also awarded a 10-year BARDA contract valued at up to $197 million to support NexoBrid procurement, vendor management inventory services, potential blast trauma indication development and next-generation manufacturing and formulation capabilities. We expect BARDA-related procurement and development to begin during the second half of 2026. This new 10-year BARDA contract builds on approximately $138 million already received from BARDA and the Department of War over the past decade, further solidifying the significance of NexoBrid as a strategic asset in mass casualty burn response and national preparedness. Importantly, the burn care community continues to move in the same direction. Newly published national consensus guidelines from Japan and the U.K. now added to existing recommendation from the WHO and countries, including Italy, Spain, Romania and Poland. To support this global demand, we remain focused on bringing our expanding manufacturing facility online. We are implementing modifications identified during a recent EMA pre-audit, and we expect to complete those implementations activities during the second half of 2026. With that, I'll turn on the call to Hani. Hani? Hani Luxenburg: Thank you, Ofer, and good morning, everyone. Let's turn to our financial results for the first quarter of 2026. Revenue for the quarter was $1.5 million compared to $4 million in the first quarter of 2025. The decrease was primarily attributable to timing of BARDA-related revenue as well as postponed shipment related to regional conflict. Gross profit for the quarter was $0.3 million, representing a gross margin of 21.9% compared to gross profit of $0.7 million or a gross margin of 18.7% in the prior year period. Research and development expenses were $5.2 million compared to $2.9 million in the first quarter of 2025, primarily reflecting continued investment in the EscharEx VALUE Phase III study. SG&A expenses totaled $3.6 million compared to $3.1 million in the same period last year. Operating loss for the quarter was $8 million compared to $5.2 million in the first quarter of 2025. Net loss was $3 million or $0.23 per share compared to a net loss of $0.7 million or $0.07 per share in the prior year period. Adjusted EBITDA loss was $7 million compared to a loss of $4 million in the first quarter of 2025. Turning to our balance sheet. As of March 31, 2026, with $45 million in cash, cash equivalents and deposits compared to $54 million at year-end 2025. During the first quarter, net cash used in operating activity was $9.6 million, including the impact of foreign exchange movement between the U.S. dollar and the Israeli shekel. Our balance sheet also benefited from $1.2 million received under the European Innovation Council (EIC) Accelerator grant program as well as $0.7 million received from the exercise of Series A warrants subsequent to quarter end. That concludes my review of the financials. Ofer, back to you. Ofer Gonen: Thank you, Hani. We continue to make meaningful progress across our core strategic priorities, advancing EscharEx VALUE study, broadening industry validation, expanding NexoBrid commercial and government footprint and preparing our expanded manufacturing facility for commercial readiness. Based on the expected timing of the government-related procurement and the development revenue in the second half of the year, we are reaffirming our full year 2026 revenue guidance of $24 million to $26 million. Our focus remains on disciplined execution as we position the company for a potential inflection point in the next phase of commercial growth. Operator? Operator: Thank you. We will now begin the Q&A session. [Operator Instructions] Today's first question comes from Josh Jennings at TD Cowen. Joshua Jennings: I wanted to just ask on the VALUE study and understand that there is some complexities in terms of evaluating some of the older patients and you described that well. But are there any other risks in terms of getting the interim analysis done by the end of 1Q '27? And has these adjustments been made already? And what are you seeing to date that gives you confidence that 1Q '27 is the appropriate new timeline? Ofer Gonen: Josh, good to speak to you. As I said, indeed, the enrollment has progressed more gradually than originally anticipated. But importantly, this is not related to, I don't know, safety, efficacy or protocol concern. As I said in my prepared remarks that the slower pace is primarily reflected by all kind of operational factors that we believe are behind us. They are associated with running a very large multinational VLU study, the largest in a few decades. And those operational challenges were, as I said, ancillary-related regulatory adjustments at certain European sites, and it is done. We estimate that we reach approximately 40 active sites within weeks. We have also implemented targeted measures to support recruitment momentum with the transportation support, reimbursement programs and additional patient assistance initiatives. So according to what we see, believe and understand from how this study runs, we expect the enrollment to be completed by the end of 2027. I have to emphasize that we are focusing on making sure that the right patients are included in the study, not patients that placebo can cure the wound or not patients that even EscharEx cannot move the needle for them. So it takes time, but we feel that we are around nearing the end. Joshua Jennings: Thanks for the extra detail. I appreciate it. And just in terms of the expanded manufacturing capacity for NexoBrid and looking at the regulators and the updates that you shared on the call, just the FDA inspection is planned in early 2027. Any just next steps on getting the FDA in there? I mean what are the steps in front of that inspection occurring in 2027? And when should we expect that facility to come online to be able to supply NexoBrid product in the U.S.? Ofer Gonen: Yes. So indeed, the U.S. inspectors are supposed to come very early 2027. But in order to do that, we need to finalize with the EMA first. As you know, it's a very complex biologic manufacturing and the transfers includes all kind of process validations, comparability, stability and regulatory reviews. These activities are progressing, but they require very careful and disciplined execution. We had -- during the quarter, we completed an on-site pre-audit from EMA. They identified all kind of several recommendations that are operational modifications. We are now implementing them. And as I said in the call, we expect to complete these activities during the second half of 2026. The feedback is operational in nature. It doesn't have anything related to product quality, safety or comparability concerns. So we think that we are on the right track. Operator: And our next question today comes from Jeff Jones at Oppenheimer. Unknown Analyst: This is Mira on for Jeff. Thanks for the update. Just a couple of questions regarding the manufacturing facility and the EMA pre-audit. Just wanted to understand sort of the impact of the recommended modifications by the EMA to the facility on material already manufactured. And what is your confidence in being able to sell that material out of the new facility before year-end and sort of that timeline to complete the implementation of these fixes? And would the EMA have to reinspect this? Ofer Gonen: Good to have you on. So as I said, responded to Josh, we -- it wasn't the inspection. It was a pre-audit by the EMA. And they identified several recommended the operational modification. And when the agency recommends something, you know it's not a real recommendation, you need to do that. So we are now implementing it. According to what we understand, we can finish everything as we planned during the second half of 2026. The feedback was only operational, nothing related to the comparability of the product, the safety of it. And these are the things that are really worrying in manufacturing transfer of biologics. So we think that we are in a good place. Unknown Analyst: Great. Just one additional question on the BARDA contract. I was wondering if you could comment on the portion of the base BARDA contract, that $35 million that goes to NexoBrid procurement and how you would expect that to flow to MediWound versus Vericel. Ofer Gonen: So the only thing that I can share about at this stage at the BARDA contract is that the $197 million is a 10-year contract between BARDA and Vericel. It contains 5 components: procurement, we share it with Vericel, VMI management. Vericel is running that. And manufacturing readiness and next-generation formulation, another indication for blast trauma, we are -- we have a big share in bringing that to the market. Certain elements in the BARDA framework also includes the room temperature stable formulation, which is a program that initiated back in the days by the Department of War. And we expect those revenue to kick in, in the beginning of the second half of 2026. Unfortunately, I cannot tell you at this stage what is the share, who gets what and what is the portion of MediWound there. Operator: And our next question comes from RK at H.C. Wainwright. Unknown Analyst: A couple of questions from me. So just thinking through the program with EscharEx beyond the current study, just trying to have an idea of how the additional studies which you are planning, especially on the indication expansion, the DFU and the IIT on pressure ulcer, how are those -- the plans for those studies and how are those studies progressing? Ofer Gonen: Thanks for joining. So as we mentioned, the Phase III VALUE study in VLU remains the primary focus of the EscharEx development program, and this is the company's key value driver, as you can imagine. In parallel, we are conducting 40 studies that are required for regulatory submission, which is a PK study and human factor studies that we are about to start in the second half of the year. We are also advancing a head-to-head Phase II study versus collagenase or SANTYL and all kind of other nonsurgical standard of care modalities also to strengthen the differentiation between us and to support -- between us and the competition and to support future market access discussions. Beyond VLU, we are expanding EscharEx into additional chronic wound indications. As we already communicated, we're about to start a Phase II study in diabetic foot ulcers in the second half of '26. As well as an investigator-initiated trial in pressure ulcers, which is planned also for the second half of 2026. This structured program is designed to support the regulatory approval, the competitive positioning of EscharEx and of course, the long-term commercial expansion across the major chronic wound segments. Unknown Analyst: The second question is on the revenues. So, there is a statement saying some of the shipments had to be postponed because of the regional conflict. So just trying to understand what sort of -- how these shipments are going to be moved into the next 3 quarters? And also, as you reconfirmed your guidance for the year, $24 million to $26 million, which means quite a bit of it is going to show up in the next 9 months. Out of that, how much is NexoBrid revenue-based income? And how much is the income that you can get from the BARDA contract approval? Hani Luxenburg: RK, so the first quarter revenue was low -- relatively low, primarily as said, due to timing. We did not have BARDA-related revenue in the quarter and certain shipments were indeed postponed due to the regional conflict. Those postponed shipments have already been completed, so this was a timing issue. As a result, we expect -- looking ahead, we expect revenue to be weighted towards the second half of 2026, driven primarily by the expected ramp-up in government-related development services and procurement activities. So our reaffirming 2026 guidance of $24 million to $26 million is, as you understand, supported by expected government-related development services with burn mass casualty preparedness. So we are quite confident that the second half of the year will do the ramp-up, and we're still reaffirming our guidance for the revenue this year. Unknown Analyst: Is it possible for me to ask one more question, please? Ofer Gonen: Sure. Unknown Analyst: Yes. So on the Medline partnership, how does that relationship help in the overall development of the product itself? And what do they bring to the table and just so that we understand their contribution to this development cycle. Ofer Gonen: Barry, do you want to speak on this? Barry Wolfenson: Sure, absolutely. RK, thanks for the question. Generally, as an overall comment, obviously, we believe that the level of industry engagement around EscharEx is highly significant. As Ofer mentioned in his comments, with Medline joining this quarter, our collaboration network essentially comprises all of the major relevant advanced wound care companies. So along with Medline, it's Coloplast/Kerecis, Convatec, Essity, Mölnlycke, Solventum, B. Braun and MIMEDX. These collaborations reflect growing recognition that chronic wound care continues to need an optimally effective, easy-to-use nonsurgical debridement solution, which we offer with EscharEx. And again, generally speaking, standardizing these key products used in both arms of the study, allowing us to only change one thing, active versus control, helps to minimize variability in the various studies and thus yield the best results. Regarding Medline specifically, the product that they're going to provide is, again, for the DFU study, and it's their class-leading cyanoacrylate-based product, Marathon. So its job is to protect the healthy skin that surrounds the wound, which is an important component of standard of wound care, and that allows EscharEx to really just do its job within the wound bed itself. So the collaborators get the benefit of having their products as standard of care in some of the largest, most substantial clinical studies in the field of advanced wound care. which could have meaningful commercial impact for their brands. Medline will be looking at data after the study with regard to the health of the surrounding or periwound tissue around the wounds to see if indeed use of their product in a large-scale study helped to keep all of that periwound in very good condition. From our perspective, the relationships with the research collaborators are strong, and any one of them could develop into a key strategic partner as EscharEx approaches commercialization. Operator: And our next question today comes from Chase Knickerbocker at Craig-Hallum. Chase Knickerbocker: Maybe just to start, could you elaborate a little bit more on that regulatory change is causing some issues in Europe? I know you talked a little bit about it last quarter, but maybe if you could just remind us. And then is this responsible for the entirety of that difference between the current kind of 30-ish sites versus kind of the 40 target? Is that delta of 10 all in Europe? Ofer Gonen: Chase, good to have you with us. Yes. First of all, the 10 sites that we are speaking about, all of them are European ones, and they will be open within weeks. As I think I shared with you in the past, specifically, some of the ancillaries that we need to import to Europe are a little bit problematic, specifically without mentioning the brand, cellular tissue products are not or were not allowed in specific countries in Europe, and it was a nightmare to bring them in. And even if we had some resolutions, they were very local and to make it on a global scale was a little bit complicated. But now we can officially tell you that we are after it and all the sites are being open, and it is going to be executed. What was the second part of the question, sorry? Chase Knickerbocker: Yes, both are. Maybe just secondly, as far as what the 1Q '27 timeline kind of assumes for an enrollment rate, does it assume kind of an acceleration? I mean, maybe just talk about the assumptions you're making within that. And then secondly, just as it relates to some of those changes around the travel reimbursement, et cetera, have you seen kind of an improvement in enrollment rate already from that? Ofer Gonen: So Barry will address the second part of the question about the changes. But as for the first Q of 2027, our assumption that the enrollment per site, the number of patients per site to be enrolled per territory will be maintained. We will have more sites and we had some -- and eventually, we'll get there. As I said in the beginning of the call, our main motivation since there is a huge need for biologics, and Barry will elaborate on that in a second, there is a huge need for biologics in the market. We just need to make it to the finish line and make sure that the trial is success. So there is no compromise in adding patients with all kind of exclusion criteria that we think will be too easy to cure for placebo or too tough to cure for EscharEx. We are keeping them out. We have more than thousands of patients that were already screened for this study. So it means that there isn't a lack of patients. We just need to make sure that the patients that are enrolled are the right ones in order for us to be able to replicate the data that we had in previous studies. Barry, do you mind addressing the second part of the question? Barry Wolfenson: Sure. I think Chase, I think that the question was directed towards whether or not these changes have impacted enrollment. And I guess what I would say about that is not likely. As Ofer just mentioned, we've had so many patients screened already. It's not for lack of patients and also talking to the sites before the study and during this last year, none of them said that anything having to do with reimbursement changes was impacting their ability to enroll patients or not. And just in general, what Chase is referring to is this major change in the Medicare Physician Fee Schedule that happened at the end of last year, which was a major change reclassifying the skin substitutes to be paid as incident to supplies and establishing a standardized per square centimeter payment, which really lowered the overall sort of amount of dollars, if you will, flowing into that segment, so much so that CMS itself stated that the change is expected to reduce Medicare spending on those skin substitutes by nearly 90%, so which effectively translates to around $12 billion out of what was a $14 billion segment. That, in turn, will drop the whole U.S. chronic wound care market from around $18 billion down to $5.5 billion. And in fact, over the last month or so, we've heard leading CTP companies reporting year-over-year declines in sales of around 60%. As Medicare closes that loophole, setting aside the clinical trial environment from a commercial opportunity, differentiated products outside this reimbursement construct will definitely stand out. EscharEx, for example, if approved, enters into a segment where a legacy product generates $400 million per year, and it places it as one of, if not the most valuable near-term asset in the field of wound care. Given the dramatic drop-off of these CTPs, certainly, the larger global wound care companies will very likely all shift their attention to products with higher order levels of regulatory approval, BLAs, NDAs, PMAs. And ours is one of the very few of those in late stages of clinical development. And I'd add it's the only one heading into an existing proven category. So from a -- while it doesn't really impact or doesn't seem to have impacted the clinical study from a commercial perspective, this change is enormous for us. Operator: And our next question today comes from Michael Okunewitch with Maxim Group. Michael Okunewitch: I think to start off, I'd like to ask a little bit about the consensus document published in Wounds. And in particular, if you could expand on what the driving rationale for the consensus on less aggressive methods earlier in the debridement course and what this could mean for EscharEx adoption? Is this something that could further build on that expectation that something like EscharEx could expand the share of enzymatic debridement in the overall chronic wound debridement segment? I'd just like to get your thoughts on that. Ofer Gonen: Michael, I think, Barry, it's the best that you respond to that, okay? Barry Wolfenson: Sure. Michael, thanks for the question. We viewed the recent consensus publication, which was in Wounds as an important external validation of the direction that the field is moving. To your question specifically about why more of a focus on less invasive modalities early, I think it's just to allow for more broad access. The higher level of complexity of the intervention, the more training that someone would need to do that. And if you know much about the wound care market, you know that wounds are treated in lots of different places from nursing homes in home care obviously, in the wound clinics and physicians' offices all the way up to and including hospitals, of course. And so there -- one of the charts that they have in the consensus document, they talk about it almost like a Chutes, and they talk about it as a Chutes and Ladders kind of approach where you start off at the base with these more easy-to-use products and then you progressively go higher and higher as it's required. And then even after you get to the top, as you sort of come down from that, you might need kind of check-ins, if you will, for maintenance debridement with the more easy-to-use products. Overall, the way that we see it and to your question of how does this -- what does this really translate to for EscharEx, the way that we view this, not that they used these words in that consensus document, but the very accurate picture that they drew of the market, the segment is one of a lot of confusion and a lot of moving parts. And the reason for that is the products that they consider to be first line, which are autolytic hydrogel types of moist wound care and the current enzymatic product are not deemed to be optimally clinically effective. Yes, they could be used in all settings. Yes, you don't need a lot of training to do them, but the debridement is measured in weeks. So that kind of forces clinicians' hands to go up that ladder and get to more invasive approaches. How EscharEx changes that entire dynamic is by, yes, having a product that's easy to use, yes, having a product that could be used across all settings, but most importantly, is optimally effective where debridement can be measured in days. According to the data from third-party research, we do believe that because of that change, that EscharEx will significantly increase the market size of the overall enzymatic debridement market. When we look at from a pricing perspective and a relative desire to switch to EscharEx between diabetic -- while SANTYL is around $400 million a year, for EscharEx, we believe that peak sales reaches up to around $831 million just from venous leg ulcers and diabetic foot ulcers alone. So yes, we do anticipate a good amount of market expansion. Michael Okunewitch: Right. And then just one more for me before I hop into the queue. Just with the enrollment challenges in VALUE, are there any lessons learned that you think you can carry over to streamline future development for EscharEx, whether that's for the supplementary studies or for the potential expansion studies into DFU and pressure ulcers? Ofer Gonen: Well, there are many lessons -- tactical lessons learned. The only one that I think is a change that we will take into account in future trials is that the enrolling rate, which is half a patient per site per month, which was a correct number when there was COVID, people were looking for excuses to go out of their home, physicians' offices were empty. These numbers should be reduced in our future calculation when we say end of Q1, we are counting on a lower number, making sure that we recruit the right patients. So all the others, additional money for transportation, make sure not to import to Europe all kind of complicated products, we are after that, and I don't think it will be an issue next time. Operator: And our next question today comes from Scott Henry at AGP. Scott Henry: A follow-up -- a bit of a follow-up on RK's question, perhaps a little more specific. How dependent is 2026 revenue guidance on increasing manufacturing capacity? And if that comes in towards the back part in Q4, is that a risk? Or can you build inventory ahead and such that you ship a lot in that quarter? Just trying to get a sense as we get later into the year. Ofer Gonen: Scott, good to hear from you. So I'm following up, Hani, if this is okay, on what you said earlier. So we -- the forecast of 2026 is dependent on -- substantially on development services from all kind of government-related agreements. Specifically, we have some flexibility. It's not that our guidance of $24 million to $26 million is assuming specific revenue from products or from revenue from development services. We know that we can do either this one or that one. We feel quite comfortable with the guidance, and we are not dependent specifically on the manufacturing capacity. Scott Henry: Okay. Great. And then when we think about the development services revenue, how should we think about 2Q? Should -- I'm assuming there was none in Q1. Should we expect that to sequentially go up through the year? Or should 2Q be perhaps a little bigger than that? Just trying to get a sense of that. Hani Luxenburg: So looking ahead, we expect revenue to be weighted towards the second half of 2026, primarily from government-related development services. We still have some revenue from development services in the first half, but it's relatively very low compared to the -- what we expect in the second half. Ofer Gonen: Don't forget that we still have an agreement with -- we have an agreement also with the Department of Force and Development Services there. So the assumption that it is 0 is not the right assumption. But definitely, it will be weighted towards the second half of the year. Scott Henry: Okay. And just one clarification. I thought I heard earlier in the remarks, you mentioned that the U.S. manufacturing capacity expansion somehow hinged on the EU manufacturing capacity expansion. Did I hear that correct? Because that would seem unusual that the 2 would be related, but I wanted to follow up on that. Ofer Gonen: Yes. It's a technical constraint. Every product that is shipped from Israel -- from Israel to the United States needs to get an approval from the local agency. The local agency is considered the European one. So before I get the approval from the EMA or Israeli local agency, I cannot ship to the United States. But again, these are not different requirements. So I wouldn't spend too much in order to understand it. But it is what it is. We need to get OK clearance from Israel and then we can ship to the United States and then we can call for audits. Operator: And that concludes our Q&A session. I'd like to turn the conference back over to management for any closing remarks. Ofer Gonen: So thank you, everyone, for joining us today. We look forward to updating you again on our next quarterly call. Operator: Thank you. That concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day. Before you buy stock in MediWound, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and MediWound wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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