MediWound Ltd. (MDWD) Q1 2026 Earnings Report, Transcript and Summary

Good day, and welcome to the MediWound First Quarter 2026 Earnings Conference Call. [Operator Instructions] Please note today's event is being recorded. I'd now like to turn the conference over to Dan Ferry of Lifesci Advisors. Please go ahead.

Thank you, operator, and welcome, everyone. Earlier today, pre-market open, MediWound issued a press release announcing financial results for the first quarter ended March 31, 2026. You may access this press release on the company's website under the Investors tab. I would ask you to review the full text of our forward-looking statements within this morning's press release. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session, relating to MediWound's expected future performance, future business prospects or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with the SEC. 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 a result of new information, future events or otherwise. This conference call is the property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. With us today are Ofer Gonen, Chief Executive Officer of MediWound; and Hani Luxenburg, Chief Financial Officer. Barry Wolfenson, EVP of Strategy and Corporate Development, is also participating 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. Ofer?

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?

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.

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?

Thank you. We will now begin the Q&A session. [Operator Instructions] Today's first question comes from Josh Jennings at TD Cowen.

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?

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.

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.?

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.

And our next question today comes from Jeff Jones at Oppenheimer.

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?

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.

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.

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.

And our next question comes from RK at H.C. Wainwright.

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?

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.

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?

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.

Is it possible for me to ask one more question, please?

Sure.

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.

Barry, do you want to speak on this?

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.

And our next question today comes from Chase Knickerbocker at Craig-Hallum.

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?

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?

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?

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?

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.

And our next question today comes from Michael Okunewitch with Maxim Group.

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.

Michael, I think, Barry, it's the best that you respond to that, okay?

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.

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?

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.

And our next question today comes from Scott Henry at AGP.

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.

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.

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.

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.

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.

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.

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.

And that concludes our Q&A session. I'd like to turn the conference back over to management for any closing remarks.

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

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.