MediWound Ltd. (MDWD) Q4 2025 Earnings Report, Transcript and Summary

Good day, everyone, and welcome to MediWound Ltd.'s Fourth Quarter and Full Year 2025 Earnings Call. Today's conference call is being recorded. At this time, I would like to turn the conference call over to Gaia Seamus of LifeSci Advisors. Please go ahead.

Thank you, operator, and welcome, everyone. Earlier today, premarket open, MediWound Ltd. issued a press release announcing financial results for the fourth quarter and full year ended December 31, 2025. You may access this press release on the company's website under the Investors tab. I would ask you to review the full text of our forward-looking statements within this morning's press release. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session, relating to MediWound Ltd.'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 Ltd. assumes no obligation to update or supplement any forward-looking statements, whether a result of new information, future events, or otherwise. This conference call is the property of MediWound Ltd., and any recording or rebroadcast is expressly prohibited without the written consent of MediWound Ltd. With us today are Ofer Gonen, Chief Executive Officer of MediWound Ltd., and Hani Luxenburg, Chief Financial Officer. Barry Wolfenson, EVP of Strategy and Co-Development, is also participating in today's call. 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 Ltd. Ofer?

Hi, and thank you, Gaia. 2025 was a pivotal year for MediWound Ltd. We ended the year with two significant growth drivers firmly in place: a Phase III VALUE trial advancing as planned, and an operational and expanded manufacturing facility for NexoBrid positioning us for long-term commercial growth. At the same time, we strengthened our balance sheet and outlined a multiyear revenue trajectory. Despite the ongoing conflict with Iran, we at MediWound Ltd. are fully prepared and will continue operating with the resilience and discipline that have guided us through similar challenges in recent years. Our team remained focused on our clinical milestones and commercial objectives, continuing to support patients and partners worldwide. Let me walk you through the progress. Let us start with an update on EscharEx, our late-stage enzymatic debridement therapy for chronic wounds. Enrollment is ongoing in the global Phase III VALUE study in venous leg ulcers, with the majority of sites active and enrolling. We are targeting enrollment of 216 patients across approximately 40 sites in the United States and Europe, and we expect both the prespecified interim assessment and enrollment completion by year-end 2026. Importantly, we are expanding the EscharEx clinical program beyond just VLUs. We have aligned with both the FDA and EMA on the Phase II protocol in diabetic foot ulcers and plan to initiate the study in 2026. In addition, a prospective investigator-initiated study in pressure ulcers is also expected to begin in 2026. This expansion broadens the clinical footprint of EscharEx across the three major chronic wound indications. We continue to see meaningful industry validation; B. Braun has joined the EscharEx clinical development program through a research collaboration agreement and will take part in the planned Phase II study in diabetic foot ulcers. This adds to the existing collaborations with Coloplast, ConvaTec, Essity, Mölnlycke, Solventum, and MiMedx. Taken together, continued clinical execution, regulatory alignment, expansion into additional indications, and industry engagement support the advancement of EscharEx as a long-term growth driver for MediWound Ltd. Now turning to NexoBrid. Our expanded manufacturing facility is now operational, increasing the production capacity sixfold to support growing global demand. Commercial availability from this site remains subject to regulatory approvals, which we expect in 2026. In the United States, adoption continues to expand, with utilization across more than 70 burn centers, representing the majority of Vericel's approximately 90 target accounts. To illustrate the driver of demand, here are some of the latest examples. Recently published real-world data from the Israel Defense Forces covering nearly 5,000 documented combat casualties showed that NexoBrid was clinically applicable in 71% of war-related injuries. In addition, a 15-year military analysis across multiple conflicts demonstrated a 50% increase in the proportion of severe burns among wounded soldiers. In parallel, we reported peer-reviewed prospective data showing that NexoBrid reduced embedded particles in ablation and blast injuries by more than 90%, supporting the role in acute trauma care. More recently, survivors in the tragic bar fire in Trans Montana, Switzerland, were treated with NexoBrid in medical centers across Switzerland, Italy, and Germany, underscoring the importance of pre-deployment of an advanced burn therapy for mass casualty events. Taking all this together, growing clinical evidence from both military and civilian settings reinforces NexoBrid's role in the treatment of severe burns. Following regulatory clearance of our expanded facility, we intend to prioritize support for national preparedness initiatives, including stockpiling and collaboration with military and emergency response systems. With that overview, I will now turn the call over to Hani. Hani?

Thank you, Ofer, and good morning, everyone. Let us turn to our financial results for the fourth quarter and full year of 2025. Revenue for the fourth quarter was $1.9 million compared to $5.8 million in 2024. The decrease was primarily driven by lower development services revenue, mainly attributable to the U.S. government shutdown, which delayed budget approval and the initiation of new contracts and agreements. Gross profit for the quarter was $300,000, or 14.9% of revenue, compared to $900,000, or 15.5%, in the prior-year period. R&D expenses were $4.5 million compared to $3.0 million in 2024, reflecting continued investment in the EscharEx VALUE Phase III study. SG&A expenses totaled $3.6 million compared to $4.0 million in the same period last year, mainly reflecting lower marketing and share-based compensation expenses. Operating loss for the quarter was $7.8 million compared to $6.1 million in 2024. Net loss was $7.2 million, or $0.56 per share, compared to a net loss of $3.9 million, or $0.36 per share, in the prior-year period. The increase was primarily attributed to lower noncash financial income from the revaluation of warrants. Adjusted EBITDA loss was $6.5 million compared to a loss of $4.9 million in 2024. Looking at our performance for the full year 2025, revenue for the year was $17.0 million compared to $20.2 million in 2024. The decrease was primarily attributable to the U.S. government shutdown and lower product sales to Vericel. Gross profit was $3.3 million, or 19.2% of revenue, compared to $2.6 million, or 13%, in 2024. The margin improvement reflects a more favorable revenue mix. R&D expenses increased to $14.0 million compared to $8.9 million in 2024, driven by investments in the EscharEx VALUE Phase III trial. SG&A expenses were $14.2 million versus $13.1 million in 2024, mainly reflecting higher marketing authorization order expenses. Operating loss for the year was $25.3 million compared to $19.4 million last year. Net loss for 2025 was $23.9 million, or $2.10 per share, compared to $30.2 million, or $3.30 per share, in 2024. The reduction in net loss was primarily driven by $2.2 million of noncash financial income from the revaluation of warrants in 2025 compared to $10.7 million of noncash financial expenses in 2024. Adjusted EBITDA loss was $20.3 million compared to $14.8 million in 2024. Turning to our balance sheet, as of December 31, 2025, we had $53.6 million in cash, cash equivalents, and deposits compared to $43.6 million at year-end 2024. During 2025, we used $21.4 million in cash to fund our operating activities. In addition, our balance sheet reflects the completion of a $30.0 million registered direct offering and $3.5 million in proceeds from Series A warrant exercises. We believe our current cash position provides the financial flexibility needed to advance our key program and continue execution on our strategic priorities. That concludes my review of the financials. Ofer, back to you.

Thank you, Hani. So before we conclude, let me briefly address our outlook. We reaffirm our revenue guidance of $24 million to $26 million for 2026, $32 million to $35 million for 2027, and $50 million to $55 million for 2028. This guidance assumes continued support from BARDA and the U.S. Department of War, and the 2028 outlook includes potential initial contribution related to EscharEx, subject to regulatory approval. These projections reflect the foundation we built in 2025 and the milestones ahead. In summary, 2025 was a year of infrastructure build-out and clinical advancement. We advanced our Phase III program for key milestones. We completed and commissioned our expanded manufacturing facility. And we strengthened our balance sheet and established a multiyear revenue framework. As we move into 2026, we are focused on disciplined execution, advancing EscharEx towards pivotal milestones, securing regulatory approvals for our expanded facility, and converting our operational progress into meaningful long-term value creation. Operator?

Ladies and gentlemen, at this time, we will begin the question-and-answer session. Using a touch-tone telephone, to withdraw your questions, you may press star and 2. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the keys to ensure the best sound quality. So, again, that is star and then 1 to join the question queue. We will now open for questions. Our first question today comes from Josh Jennings from TD Cowen. Please go ahead with your question.

Morning. Thank you for taking the questions, and I hope everyone on the team is safe, and we are thinking about you guys. I wanted to start with just a question on NexoBrid and the manufacturing expansion project that has been successful. Just maybe review the pent-up demand in international regions and the timing. I think you can take this all into your multiyear guidance forecast, just the timing of MediWound Ltd. filling that demand over the next 12, 18, 24 months.

Hey, Josh. Good speaking with you. So our expanded manufacturing is now operational, and the capacity has now increased sixfold. The commercial output in this site remains subject to regulatory approvals that are expected later in 2026. Once we are approved by EMA or FDA, the product that we are manufacturing during the validation process that we are doing now can be released to the market. Our guidance assumes a regulatory approval clearance in 2026. I think it is an assumption that we believe is reasonable given where we stand today. As for the demand, it is much larger than we can actually manufacture across the territories. Having said that, I do not know if it will be the case once we can manufacture. Therefore, we guided according to what we expect, and I hope it will be better going forward.

Thanks for that, and congratulations on the pace of the VALUE trial, and it sounds like things are going well there. I wanted to ask about the pressure ulcer trial. It is my understanding that, just in terms of your team's assessment of the peak sales in the U.S. down the line for EscharEx, it does not include contributions from the pressure ulcer indication. Maybe just talk about or review the size of that opportunity in the U.S. and how that will be unlocked with this trial. Thanks for taking the questions.

I have to admit that I did not hear anything. Is it because of my line or because of yours? Do you hear me? I am sorry. It may have been because of my line. Can you hear me now? I do not hear you. Operator, is it his line? Should I reconnect?

I am hearing both of you. Are you able to hear me, sir? Can you, sir?

Yes, I hear you loud and clear. Josh, can you speak again?

Certainly. Can you hear me now?

Yes. Can you repeat the question? Sorry.

Sorry for the technical difficulties. Maybe that was on my line. Yes, I was just saying that you are making nice progress on the VALUE trial, which is a good signal. I just wanted to dive a little bit deeper into the pressure ulcer indication. My understanding is that that is not included in your team's assessment or forecast of peak sales in the U.S., which is a little bit of conservatism there. But just wanted to either review that pressure ulcer indication and the kickoff of this pressure ulcer study later this year. Thanks for taking the question.

Okay. Barry, do you want to take this one?

Sure, absolutely. As you know, we are going to start an investigator-led pressure ulcers study this year, and along with that, we will have a third-party market research project initiated that will replicate what we did with regard to diabetic foot ulcers and venous leg ulcers. And so, ultimately, those peak sales, as you mentioned, will increase. I think from a back-of-the-envelope perspective, I would say to think about pressure ulcers as the third of the big three ulcer types along with DFUs and VLUs. There are probably more pressure ulcers than there are the other two. We still need to do the work to see how many of them require debridement and would be applicable to EscharEx. But back of the envelope, I would anticipate that when all is said and done, it will be roughly a third of the business.

Thanks for that, Barry and Ofer. Appreciate it.

Our next question comes from Jeffrey Jones from Oppenheimer. Please go ahead with your question.

Thank you very much for taking the question. Josh and Ofer, I hope everyone is safe there. You mentioned in the 2026 revenue guide that this assumed continued support from BARDA and DOW. Can you clarify how much of that is based on new contracts that are not currently committed versus the award that you are anticipating, and perhaps give us an update on what you know there?

Hi, Jeff. So good to have you on as well. Let us start with BARDA. In August 2025, BARDA issued an RFP covering stockpiling, warm-temperature stable formulation, and trauma and blast injury indications. Vericel, which holds the U.S. commercial rights on NexoBrid, is leading the process in the United States. We will provide full technical and development support. Now, with federal operations normalized, we expect BARDA to resume progress on this RFP and related development and procurement activities, subject, of course, to standard government processes. I cannot add more to that. As for our collaboration with the Department of War, as you know, NexoBrid room-temperature stable formulation is being developed for a nonsurgical burn treatment for the use for the U.S. Army. We have been awarded to date a total of $18.2 million in nondilutive funding from the U.S. department for order to support this development. We are moving forward. So part of the revenue is supposed to be from BARDA and part of it from the Department of War.

Thank you for that. You mentioned the research collaboration in the context of the DFU study, I believe. Can you speak in a little more detail about what some of these collaborators are providing and how that guides to your long-term strategy in VLU, DFU, and beyond?

Okay. Barry, do you want to speak on this?

Sure. I mean, as you mentioned in the call, between the VLU and the DFU study, at this point we have seven of these research collaborations, all with market-leading advanced wound care companies. They include Coloplast, through their acquisition of Kerecis, Essity, Solventum, Mölnlycke, ConvaTec, MiMedx, and now the most recent one being B. Braun. Just a little bit about B. Braun: they are one of the world's leading privately held medtech companies. They are headquartered in Germany, founded in 1839. They generate over $9 billion in annual revenue, operate in over 60 countries, and employ more than 60,000 people globally. They are known for products that are used daily across hospitals, surgical centers, dialysis clinics, and outpatient settings, so they are a perfect partner when it comes to wound care. They have a big wound care franchise. Specifically with B. Braun, they are taking part in the DFU Phase II study. As with the other collaborators, they will be supplying one of the key products that is for optimal care of wounds, which will be used in both arms of the study. Specifically, they are supplying their market-leading antimicrobial wound cleanser, Prontosan, to be used during dressing changes. So each of these collaborators are putting in one kind of product, whether it be a wound dressing. In the VLU study, compression therapy is required. Post wound healing, there is a different kind of compression device that keeps everything in place. So they all supply things that are needed for the standard of care in wound care, and it allows for the study design to be that only one thing needs to be changed between the two arms, and that is the active and the control, and so it reduces any sort of variability in the study, and we get cleaner results. For the companies, the collaborators, they get the benefit of having their product used as standard of care in these very, very large, hopefully successful studies, and it also provides the opportunity for relationship building between MediWound Ltd. and these collaborators. So as we get closer to the product making it to the market, and if there are any partnering transactions to consider, all these companies will be up to date with the program, know the details of it intimately, and it will just facilitate conversations at that time.

Great. Thank you very much for the detail. We will get back in queue.

Thank you. Our next question comes from Swayampakula Ramakanth from H.C. Wainwright. Please go ahead with your question.

Thank you. This is RK from H.C. Wainwright. Good afternoon, Ofer, and I am glad to hear your voice. Just a couple of quick questions. On the VALUE trial, which includes the provision of adaptive adjustment that you could do at a 65% enrollment mark, what clinical scenarios would there be if you had to increase your sample size, and if you end up doing that, what sort of an impact would it have on your timeline?

Hi, RK. So thank you for joining. Yes, as you mentioned, the prespecified interim sample size assessment will be conducted after approximately 65% of the patients complete the treatment. Based on this assessment, the study may continue as planned, which means that the sample size stays 216 patients. The sample size may increase if necessary. We want to preserve the approximately 90% statistical power. As you know, at MediWound Ltd., we succeeded in all the 14 clinical trials that we conducted and all the three Phase II studies that we conducted with EscharEx. So we have no intention not to make it to the finish line in this study as well. So the outcome could be the study should finish the enrollment as planned, which means 216 patients, and as we guided, it would be by the end of 2026. If, let us say, we are at 80% statistical power, not good enough, we will increase the number of patients. If it is increasing by 20–40 patients, it means adding another couple of months to the study and another few millions of dollars, which is not a drama. If the outcome is that we need to increase it by 100 patients, it will be at least six months, and it will cost us another $10 million. Let us hope that the data will be very similar to what we saw in the Phase II studies, and we will be able to finish the enrollment by the end of this year.

Thank you for that. And then the question I have on supply chain for the clinical studies: as we understand how things are in and around Israel at this point because of what is going on in the geopolitical world, is that impacting anything in terms of supplying clinical product to the various centers, and if so, how are you managing it?

So it is a great question because we just had a discussion about it this morning. We checked in across the sites in Europe and in the United States. There is enough EscharEx that can support continuation of the trial for the next at least six months, so we are in a good place. On top of that, the other ancillaries are from global companies, so all of them should be in the sites. So we do not anticipate any issue regarding the supply chain that will impact the clinical study.

Thank you for that. And then the last question from me is, the revenues for 2025 were below what was expected, and is that partially a stocking issue through Vericel, or is it the pull-through in some of these active burn centers?

RK, so the revenue for 2025 totaled $17.0 million, as you said, less than the $24.0 million that was expected. The decrease was primarily due to the U.S. government shutdown, which delayed, as you imagine, the budget approval and the initiation of new contractual agreements. There was a small part that belonged to the sales to Vericel, but the main part is the U.S. government shutdown.

So when you say that, I was just wondering about the 2026 revenue guidance. How much of the BARDA RFP award expectation is in the $24 million to $26 million that you are talking about?

We are not sharing the split. We have potential of getting from BARDA, potential from or indirectly by Vericel. We have potential to get it from the DOW, and we have revenue from product. We feel comfortable achieving the $24 million to $26 million, but we are not giving the split.

Thank you. Thank you both for taking all my questions.

Next question comes from Chase Knickerbocker from Craig-Hallum.

Hello, everyone. This is Jake on for Chase. Wondering if you could provide a little bit more color and further discuss the decision to move forward with a Phase II for DFU rather than the adaptive Phase II/III design as previously planned. What kind of feedback from the FDA did you receive that indicated that this was the best path forward?

Hi, Chase. Good to have you with us. So the main program, as you know, is the VLUs, and we decided to expand the program into two additional chronic wound indications, as said, DFU and pressure ulcers. There are some changes in the administration. We are not certain that it will be required to execute a very large Phase III study in order to have an approval for a DFU indication. We consulted with the agencies, both with EMA and FDA, asked them what they are expecting to see in order to see the advantage of EscharEx in treating DFU patients, and the outcome was this study with 50 patients, as we detailed in our corporate deck. And if I may add, it is a 50-patient study, which is the kind of Phase II, and if we see that we need to have additional, I do not know, 100, 150 patients to finalize the Phase III, we will do it study after study. So it is a kind of a timing impact, but we are not certain that it will be done before the product is approved.

Appreciate that color, Ofer. That is helpful. And then same type of question on the pressure ulcers. Is it your understanding that the pressure ulcer would require a separate Phase III to get the potential EscharEx label?

Thank you for the question. As Ofer intimated in his answer with regard to DFUs, there is a change in the stance with regard to the FDA and how they are trying to make it, let us say, easier for drugs to be approved, the most notable thing being that they are moving from the need to do two well-designed, well-controlled Phase III studies in order to get approval, and they are moving that to needing only one. And when we look at that, and we also look at, if you recall, at the end of last year, the FDA agreed that our second primary endpoint would be the facilitation of wound closure, which basically takes the onus of the closure portion away from EscharEx and puts it into the hands of already approved products like a CTP or an autograft. We intend to have a discussion with the FDA around the necessity of these large-scale Phase III studies for each and every indication, i.e., DFU, pressure ulcers, or any other chronic wound indication that is out there. The necrotic material on these wounds is all very similar from wound to wound to wound. We have excellent data and a growing base of data that EscharEx works on all of that necrotic material, owing to its several different enzymes that are in the API and multiple different targets towards the necrotic material. And we believe, in the end, that it would be likely sufficient to have, as we are doing in the DFU study, a well-designed Phase II study complemented by post-marketing real-world data to expand the pack insert to include additional indications.

Appreciate that additional color, Barry. Thanks for taking the questions.

Thank you. Our next question comes from Michael Okunewitch from Maxim Group.

Hey, guys. Thank you so much for taking my questions today. I guess to start off, I would like to ask a little bit about the pressure ulcer program, and in particular, the strategic considerations around prioritization in chronic wounds. We know about the prioritization between VLUs and DFUs, but pressure ulcers do seem to be a little bit overlooked in this market. So I am curious if you could comment on the market and why pressure ulcers seem to be prioritized less so than the other two chronic wounds.

Hi, Michael. I do not think it is less prioritized. The largest unmet medical need is definitely at venous leg ulcers, because these wounds are extremely painful, and you do not have any alternative. The knife, the scalpel, is not an alternative for that. Pressure ulcers are very different one from another, might be very deep. There are all kinds of complications that might be associated. For us, it seems to be the more complicated ones to treat. So we are going to start with relatively mild pressure ulcers. Having said that, it is important for us, as Barry said previously, EscharEx works on burns, it works on wounds, it does not care which type of wounds it is applied on. So our motivation is making sure that when we are very close to the finish line, having data in our venous leg ulcer trial, to make sure that everyone understands—the potential partners, the investors—that everyone understands how large this market is and how big is the unmet medical need. So the current trial with pressure ulcers will be a very small trial. We will do in parallel, as Barry said, that just demonstrates that EscharEx can debride. By a third-party consultant and market research, we will understand exactly the portion of the patients that need to debride their wounds, and only then we will know how large is our accessible market. I hope I answered your question.

Thank you. I appreciate that. And then could you just provide an update on the status of the head-to-head study? Are there any additional outstanding items before you can get that up and running?

Yes. So, as you know, the main focus of the company, and this will definitely determine our value, is the Phase III study. In parallel, we need to conduct some supportive studies that we are doing. One of them is a PK study, for instance, one of them is a human factors study. We are doing all kinds of small trials to support the BLA submission. Specifically regarding the head-to-head study versus collagenase or other types of nonsurgical standard of care, we are doing that in order to support future market access discussions. We guided, and we are going to do that, that we will start the trial around mid this year, maybe the second part of the year. For us, it is a very important study, since it will enable us to determine what the actual price of EscharEx will be.

Alright. Thank you. And then one last one for me before I hop into the queue. In terms of your enrollment, the complete enrollment targets for the VALUE study and the interim analysis, is that based on the current rate of enrollment, or does there need to be some additional ramp or acceleration at the sites to meet that?

To protect the study integrity, we are not sharing enrollment numbers or trends. But we feel very comfortable with the target that we gave, which means interim assessment and completion of the enrollment of the study by the end of the year.

Alright. Thank you very much for taking my questions today.

And our next and final question for today comes from Scott Henry from A.G.P. Please go ahead with your question.

Thank you, and good afternoon. First, just to clarify, as far as the interim analysis, when you talk about year-end, should we expect that to mean Q4?

Hi, Scott. I would expect it to be by year-end.

Which means in the end, in the end of Q4.

I do not want to overpromise.

Okay. That is helpful. Thank you, Ofer. And then with regards to revenue and timing, as far as the BARDA revenues, I assume there were none in 2025. Should we expect any revenues in 2026? Just a couple of weeks left in the quarter. You might have a sense at this point.

So once BARDA agreement is signed with Vericel, I guess all of us will know. Our revenue guidance assumes that the initial revenue from those specific agreements will be only from Q2.

Okay. Great. So when we do model this out, just confirming, we should really expect a pretty significant increase in revenues in 2026 over the first half of 2026, given the manufacturing capacity coming on stream, given the BARDA revenue. So just want to make sure I am thinking about that correctly. Thank you.

Yes. Scott, it was always that the second half is better in revenue than the first half. Of course, given the fact that in our model BARDA's revenue will be only recorded from Q2, and also the capacity will increase at year-end or the second half. You are very much correct.

Okay. Great. Thank you for taking the questions.

Thank you so much.

And ladies and gentlemen, with that, we will be ending today's question-and-answer session. I would like to turn the floor back over to management for any closing remarks.

Thank you, everyone, for joining us today. We look forward to updating you again on our quarterly call.

And with that, we will conclude today's conference call and presentation. We do thank you for joining. You may now disconnect your lines.