MediWound Q3 2026 Earnings Call Transcript

MediWound (NASDAQ:MDWD) reported third-quarter financial results on Thursday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

MediWound reported a decrease in Q3 2026 revenue to $3.6 million from $5.4 million in Q3 2025, primarily due to lower revenue from U.S. government development services. Gross profit increased slightly to $1.0 million with improved margins.

The company is advancing its EscharEx Phase 3 VALUE trial, expecting enrollment completion by Q1 2027. Discussions for potential commercial partnerships for EscharEx are ongoing, with a strategic focus on large wound care companies.

NexoBrid’s U.S. commercial trajectory is strong, with the highest quarterly revenue since launch and significant government procurement under the BARDA contract. Manufacturing capacity is being expanded to meet global demand, with the expanded facility expected to be operational in H2 2027.

MediWound’s recent public offering raised $17.25 million, strengthening its balance sheet and providing financial flexibility. The company’s future revenue is significantly tied to U.S.-based manufacturing facility development, with funding discussions ongoing.

Management highlighted the strategic importance of EscharEx due to its potential market impact, projected at $1 billion in U.S. peak sales across chronic wound categories.

Full Transcript

OPERATOR

Good day and welcome to MediWound’s third quarter 2026 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today’s presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded at this time.

I would now like to turn the conference over to Gaya Shamis of LHA. Please go ahead.

Gaya Shamis (Investor Relations)

Thank you, Segur, and welcome, everyone. Earlier today, before the market opened, MediWound issued a press release announcing financial results for the third quarter ended September 30, 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 view only as of today and MediWound assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. This conference call is the property of MediWound and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. With us today are Ofer Gonen, Chief Executive Officer of MediWound; Hana Kalfon 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 (Chief Executive Officer)

Thank you, Gaya, and good morning, everyone. During the third quarter, we advanced EscharEx development, supported NexoBrid’s commercial growth and government program, and continued preparing our expanded manufacturing facility to meet future demand. Let me start with an update on EscharEx. The global Phase 3 VALUE trial in venous leg ulcers remains our top priority. Enrollment continues, and we remain on track to complete the prespecified interim sample size reassessment and the enrollment by the end of the first quarter of 2027. The current enrollment target is 216 patients across approximately 40 sites in the United States, Europe, and Israel. During the quarter, the Independent Data and Safety Monitoring Board completed its prespecified periodic review of the VALUE trial, identified no safety concerns, and recommended that the trial continues as planned without modifications.

The next DSMB meeting is scheduled for early January 2027. The following meeting is expected at the end of the first quarter of 2027, at which the DSMB will also conduct the interim sample size reassessment. Beyond venous leg ulcers, we continue to advance towards clinical trials in diabetic foot ulcers and pressure ulcers. The diabetic foot ulcer program has received grant funding from the European Innovation Council and is supported by strategic collaborations, while work on pressure ulcers is investigator initiated. Once final results from the VALUE trial are available, we plan to discuss the development pathway for additional chronic wound indications with the FDA.

Turning to NexoBrid, the U.S. commercial trajectory continues to strengthen. Vericel reported NexoBrid’s strongest quarter since launch, with its highest quarterly revenue to date, driven by the highest number of ordering burn centers and hospital orders. Even more new centers ordered NexoBrid in the first nine months of 2026 than in all of 2025. More than 80 centers have placed orders to date, with approximately 70 placing repeat orders. Government procurement under Vericel’s BARDA contract began in the third quarter and, as Vericel indicated, is expected to continue through 4Q26 and the first quarter of 2027.

We continue to collaborate with Vericel in advancing two NexoBrid development programs under our Master Service Agreement: indication expansion to acute trauma injuries associated with thermal burns and development of a new stable formulation. Both programs are covered by the contract between Vericel and BARDA. Separately, the Department of Defense awarded MediWound an additional $3.3 million in nondilutive funding to advance the room-temperature stable formulation of NexoBrid as a nonsurgical debridement solution for battlefield burn care.

This brings the program’s total budget to $21.8 million and is intended to support the development through submission of an IND application. Together, these programs are intended to broaden NexoBrid’s potential applications in civilian and military burn care beyond the United States. Demand for NexoBrid extends across Europe, Japan, and other markets. However, global demand currently exceeds our manufacturing capacity, limiting our ability to fully meet the needs of these markets. Expanding our capacity is therefore a key priority for us. Let me provide some context on our manufacturing operations, starting with our current NexoBrid facility. The facility successfully completed routine GMP inspections by the FDA and the Israeli Ministry of Health, with the Ministry also conducting its inspection on behalf of the EMA.

The facility’s GMP certification is valid now for an additional two years. To address the capacity constraints and support the future demand, we are advancing our expanded NexoBrid manufacturing facility. We are implementing the modifications recommended during the previously reported EMA pre-audit and expect to complete this work in the fourth quarter of 2026 as planned. 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 Hana.

Hana Kalfon Luxenburg (Chief Financial Officer)

Thank you, Ofer, and good morning, everyone. Before I walk through the numbers, let me put our results in context. Our revenue is heavily weighted toward development services for U.S. government programs. Product sales, meanwhile, are constrained by supply rather than demand. We are selling every unit we can manufacture. On the expense side, our main investment is in R&D, mainly the EscharEx Phase 3 VALUE trial. We expect spending on that trial to decline substantially as it reaches completion.

Now turning to our financial results for the third quarter of 2026. Revenue for the quarter was $3.6 million compared with $5.4 million in 3Q25. The decrease was primarily attributable to lower revenue from development services related to the U.S. government. Gross profit was $1.0 million, representing a gross margin of 28.5%, compared with gross profit of $0.9 million, or 16.5%, in the prior-year period. The margin improvement primarily reflected higher contribution from royalty revenue, which carries higher gross margin.

Research and development expenses were $6.2 million compared with $3.5 million in the third quarter of 2025, primarily reflecting increased investment in the EscharEx Phase 3 VALUE trial. SG&A expenses totaled $3.4 million compared with $4.0 million in the same period last year. The decrease primarily reflected lower marketing expenses. Operating loss was $8.5 million compared with $6.5 million in the third quarter of 2025. Net loss was $6.0 million, or $0.47 per share, compared with a net loss of $2.7 million, or $0.24 per share, in the prior-year period.

The year-over-year change primarily reflected lower non-cash financial income from revaluation of warrants. Adjusted EBITDA loss was $7.4 million compared with a loss of $5.4 million in the third quarter of 2025. Turning to our results for the first nine months, revenue for the first nine months of 2026 was $8.1 million compared with $15.1 million in the first nine months of 2025, primarily attributable to lower revenue from development services related to the U.S. government. Gross profit of $3.0 million or 19.7% in the prior-year period. The margin improvement primarily reflected a higher contribution from royalty revenue. Research and development expenses were $17.3 million compared with $9.8 million in the first nine months of 2025, primarily reflecting increased investment in the EscharEx Phase 3 VALUE trial.

SG&A expenses totaled $10.8 million compared with $10.6 million in the same period last year. Operating loss was $26.0 million compared with $17.5 million in the first nine months of 2025. Net loss was $16.3 million, or $1.27 per share, compared with a net loss of $16.7 million, or $1.53 per share, in the prior-year period. The change primarily reflected non-cash warrant revaluation income of $10.3 million in 2026 compared with $1.8 million in 2025.

Adjusted EBITDA loss was $22.7 million compared with a loss of $13.8 million in the first nine months of 2025. Turning to our balance sheet, as of September 30, 2026, we had $28.4 million in cash, cash equivalents, and deposits, compared with $53.6 million at year-end 2025. Cash burn during the first nine months of 2026 totaled $28.3 million. Warrant exercises generated $2.0 million during the first nine months, and we received an additional $1.1 million after quarter-end. Those exercising warrants included all board members who held warrants, the company’s founder, and our CEO, each of whom also agreed to lock-up restrictions.

In addition, in November 2026 we closed an underwritten public offering, including the full exercise of the shoe option, for gross proceeds of $17.25 million. This concludes my review of our financial results. Ofer, back to you.

Ofer Gonen (Chief Executive Officer)

Thank you, Hana. We are advancing EscharEx, supporting NexoBrid’s commercial growth, and expanding our manufacturing facility. Our recent public offering strengthened our balance sheet, giving us additional financial flexibility through and beyond the VALUE data readout. We continue to work with the U.S. government to secure funding for our planned U.S.-based manufacturing facility. A substantial portion of our anticipated 2026 revenue is tied to development services for this project.

We do not yet know when or whether funding will be secured and, as a result, our 2026 revenue outlook depends on these ongoing discussions. Our priorities are clear. First, complete the VALUE interim assessment and enrollment by the end of the first quarter of 2027. Second, support NexoBrid with continued commercial growth. We’ll do that by bringing our expanded facility into operation and by advancing new indications. With that, we are ready to take your questions.

OPERATOR

Thank you. We will now begin the question-and-answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Your first question comes from Josh Jennings with TD Cowen. Please go ahead.

Josh Jennings (Analyst)

Hi Ofer, Hani and Barry, thanks for taking the questions and appreciate the download today and the update. Wanted to just ask on VALUE trial enrollment. You reiterated expectations for the completion of enrollment by the end of 1Q. It’s great to hear, but maybe if you can just help us better understand your confidence in achieving that milestone within the next four to five months. Any more granularity you can provide just on recent enrollment velocity?

Ofer Gonen (Chief Executive Officer)

Hi Josh, good to speak to you. As for the VALUE, we feel very comfortable. We had some hiccups in the past, as you know, especially about opening sites in Europe. Currently, we feel comfortable 95% of the sites are open. To protect the study integrity, we are not sharing patient enrollment numbers or enrollment trends during the conduct of the study. Having said that, if we plan on the 216 patients with the roughly 40 sites that are open, we are very comfortable in this guidance of the end of the first quarter of 2027.

Josh Jennings (Analyst)

And just wanted to better understand, or maybe you could map out, potential timing for the data readout for VALUE. Assuming that the enrollment is completed by the 1Q and the interim sample size reassessment leads to no change, what’s the required patient follow-up, data cleaning process, and the other factors that could influence the timing of the top-line results being made public?

Ofer Gonen (Chief Executive Officer)

So the protocol includes a pre-specified interim sample size reassessment after we finish the treatment of 140-ish patients. This is in order to confirm the targeted 85% statistical power. Based on that assessment, we will either finish the enrollment of the 216 patients or increase the sample size under the current 216-patient design back to finish the enrollment, as I said, by the end of the first quarter. After that we have around three months of treatment, another couple of weeks of aggregating the data.

So I would expect the top-line results in mid-2027.

Josh Jennings (Analyst)

Actually, maybe just one more. Sorry for adding another question under my session here, but just wanted to talk about the commercial strategy for EscharEx and, you know, partnership versus independent launch. As you’re moving VALUE, advances towards the pivotal readout, how are your discussions with potential commercial partners evolving? Are they waiting for the Phase 3 results or could a transaction or partnership occur ahead of the readout? Thanks for taking all the questions.

Ofer Gonen (Chief Executive Officer)

So I don’t want to comment on discussions with specific companies or on whether any are taking place right now, but what I can do is explain why we believe that EscharEx is a strategic asset for the large wound care companies. First, the market has shifted after the CMS cut of the skin substitutes reimbursement. Companies with large wound care sales forces are now looking for products approved through BLA, NDA, or PMA with an established reimbursement path. To our knowledge, EscharEx is the only late-stage BLA candidate of its kind. So this is, I think, the main reason for the attractiveness of EscharEx.

Second, the product profile. If EscharEx is approved, if you compare it against the single decades-old Santyl, which has more than $400 million in annual sales and takes four to eight-plus weeks to achieve what EscharEx has shown in four to five days on average, it is considered very significant in wound care. And third, the size of the opportunity. We project approximately $1 billion in U.S. peak sales across venous leg ulcers, diabetic foot ulcers, and pressure ulcers, the three largest chronic wound categories. And we believe that this is an opportunity that no major wound care company can ignore. You can see that by the engagement of our collaborators — we have eight out of the nine larger wound care companies that are collaborating with us. Our focus is delivering on the VALUE data, and I think after that we have the flexibility to get a decision on our own timeline.

I hope I answered your question.

Josh Jennings (Analyst)

Yes, understood. Thank you.

Ofer Gonen (Chief Executive Officer)

Thank you.

OPERATOR

Thank you. The next question comes from Swayambakula Ramakanth with HC Wainwright. Please go ahead.

Swayambakula Ramakanth (Analyst)

Thank you. Good afternoon, Ofer and Annie, and morning Barry here. Couple of questions on the expanded facility. After the modifications that you need to do during the fourth quarter, what is left in terms of validation, inspection, and release milestones that you’re expecting for the second half ’27 commercial supply? And also, is there any timing cushion that you have included into it so that if things get shifted you still could achieve that milestone of second half ’27?

Ofer Gonen (Chief Executive Officer)

So hi RK, and thank you for joining. As for the expanded facility, as I mentioned in my prepared remarks, we expect the work — the recommendation that we got in the pre-audit to do some operational changes — we expect to finish that work in the fourth quarter of this year. Once that work is complete, we will start manufacturing NexoBrid at the new facility. Then we will need to submit it. There is a review process, there is an on-site inspection, and then we can sell that specific commercial supply.

For the expanded facility, we are targeting the second half. Second half — it’s a six-month period and there is some cushion there, but we do not expect it to be earlier.

Swayambakula Ramakanth (Analyst)

Very good. With 70 repeat ordering centers in the U.S. and also the BARDA procurement has started, so what are the constraints now for incremental supply, especially before you can get that expansion approved? And congratulations on the current facility going through all their recent inspections. Does that facility have enough capacity to handle what is happening or what the demand is asking for here in the U.S., and is that all included into your guidance at this point?

Ofer Gonen (Chief Executive Officer)

So, as I said in the call, we are quite limited in our ability to manufacture. We have no issues in demand. We need to prioritize who we sell NexoBrid and when. The United States market gets the priority. We are in a position to give the supply that is required to Vericel for the commercial use and also for the procurement of BARDA. This is our top priority.

Swayambakula Ramakanth (Analyst)

So the last question is on the revenue outlook. I understand the inability, you know, with regards to the separate U.S. facility and why you cannot get to a proper guidance as yet. However, what is already included into your previous guidance in terms of how much of the executable work in that project has been included or not included, and is there any additional color you can provide around that?

Ofer Gonen (Chief Executive Officer)

So our revenue is heavily weighted towards development services for the U.S. government programs, as you know, and it has a few pillars. Under the agreement with Vericel, we continue to support two NexoBrid development programs. Both of them are covered by the contract with Vericel and BARDA: the indication expansion to acute trauma injuries and the development of a new stable formulation. Separately, we have income from the Department of Defense.

They awarded us an additional $3.3 million to develop the room-temperature stable formulation. As I said, on the product side, NexoBrid sales are constrained by supply, so we have visibility towards what we can generate revenues there. We are selling every unit that we can manufacture, including all the products — I’m referring to your previous question — including products for the government procurement under the Vericel–BARDA contract. The key uncertainty, and we highlighted this, is the U.S.-based manufacturing facility. A substantial portion of our anticipated 2026 revenue is tied to that.

We are still in ongoing discussions with them — all kinds of funding discussions that I cannot get into details now — and I don’t know when it will be secured.

Swayambakula Ramakanth (Analyst)

Thank you. Thanks for taking all my time.

OPERATOR

Thank you. Your next question comes from Meera Sharma with Oppenheimer. Please go ahead.

Meera Sharma (Analyst)

Hi, this is Mira on for Jeff. Thank you for taking our question. We were just wondering if you could give a bit more guidance on how you think 2026 and 2027 will shake — U.S. government and BARDA revenue — and how will we see the first curve of 2027 to be impacted, especially for the EscharEx VLU trial timelines and for the other two indications as well for DFU and pressure ulcers. Thank you.

Ofer Gonen (Chief Executive Officer)

Hi. As for the EscharEx, as I said, the guidance is very clear: interim assessment first quarter; assuming the base case happens, we expect top-line results mid-2027. We will start in parallel — we are finishing the preparations for both pressure ulcers and diabetic foot ulcers. We will give color when we initiate this trial, and I guess at least the first one will be in the next few. So in EscharEx I think the guidance is quite clear. Did you also ask about NexoBrid?

Meera Sharma (Analyst)

No. Thank you. That’s it.

Ofer Gonen (Chief Executive Officer)

Okay. Thank you.

OPERATOR

Thank you. Your next question comes from the line of Chase Knickerbocker with Craig Hallum. Please go ahead.

Nick Matiacchi (Analyst)

Hey guys, this is Nick Matiacchi on for Chase. Thanks for taking our questions. So I think you guys mentioned in the prepared remarks that there will be a couple additional Data Safety and Monitoring Board meetings for VALUE in the first quarter. Can you just walk us through what will be assessed at those meetings and how those reviews relate to the sample size reassessment, and what information we should be looking out for from those meetings?

Ofer Gonen (Chief Executive Officer)

Hi. So as we guided in the past, we have DSMB that will be unblinded and look at the data once 140 patients finish the treatment. But separately, we have the DSMB review safety at pre-specified points during the clinical study. At each review, the DSMB has all kinds of options of recommendations, such as continue as planned; continue but make some protocol changes; a temporary hold until the changes are made; or they can even stop the trial if they see major safety concerns.

As we reported previously, the most recent DSMB recommendation was everything looked great, continue as planned without making any modification. The next DSMB review is expected in early January, the first week of January, and then the following meeting is expected to be at the end of the first quarter, and the DSMB there will also conduct the interim sample size reassessment as we discussed earlier. I hope it was clear.

Nick Matiacchi (Analyst)

Yeah, got it. Thanks for that. And then I think this was already touched on a little bit, but just as we think about the top line and the previous range you guys provided for 2027, are you able to share any color on what portion of that range will hinge on the progress with the U.S. manufacturing facility?

Ofer Gonen (Chief Executive Officer)

So, as we said, it’s a major part of the — it’s a significant part of the $24 to $26 million guidance. We are not providing — we are not prepared now to say how we break out this component of the guidance, only to share that the substantial portion is tied to development services for the planned U.S.-based facility.

Nick Matiacchi (Analyst)

Understood. Thanks for taking our questions.

Ofer Gonen (Chief Executive Officer)

Thank you.

OPERATOR

Thank you. The next question comes from Michael Okunovich with Maxim Group. Please go ahead.

Michael Okunovich (Analyst)

Hey guys, good morning. Thank you for taking my questions.

Ofer Gonen (Chief Executive Officer)

Good morning.

Michael Okunovich (Analyst)

I wanted to ask just a little bit about the VALUE study, the upcoming DSMB review, and in particular what change in the incidence of complete debridement or wound bed prep is the study powered for under the current target enrollment of 216 patients?

Ofer Gonen (Chief Executive Officer)

So the VALUE trial is very similar to a trial that we did which was called ChronEx, which is a Phase 2 trial. There are some differences that we believe fit better the ability to demonstrate EscharEx advantage over placebo. All the power calculations were based on the previous trial. The changes that we made in this trial hopefully make the probability of success better, based on the fact that we standardized the treatment — all the patients are getting identical treatments across many sites — and based on the fact that we removed patients from the trial that are too easy to treat or very complicated to heal.

We believe that it will increase substantially the gap between the active EscharEx to a placebo. But the 216-patients calculation is based on the previous Phase 2 trial. Okay, this is a great question. So we have two primary endpoints. The first one is the incidence of complete debridement. In order to prove that EscharEx is better than placebo in debridement, you don’t need 216 patients. According to our calculations, you need less than 20 in order to show that it is much better. Because basically, if you recruit the right patients, and this is what we are focusing on in this trial, the gap between the two arms should be significant.

So no one is looking at the placebo. Assuming the 216 patients is 99.9% powered to beat this specific endpoint, the only thing that the DSMB are looking at is the difference in the time to facilitate wound closure. And this is what they’re looking at. Only that. So, as I said, the phase 3 VLU study, this is our primary focus on EscharEx. We are conducting beyond VLU. We see EscharEx addressing diabetic foot ulcers and pressure ulcers. And together with VLU, these are the three largest chronic wound categories. And the market size that we discussed last time was around $1 billion. Potential big sales or potential opportunity.

We are now preparing for the broad development of the program. Both of the studies are getting ready for initiation. We will have some news about it in the next, I guess next call or next few weeks. The first trial is the pressure ulcer, which is an investigator-initiated. It means that it is not directly run by us. It will be a small open-label trial. And the second one is the DFU 50-patient study supported by the European Innovation Council. And this will be a larger trial, double-blinded.

This specific trial is supported by some of the large collaborators that we discussed in the prepared remarks. I hope it was clear. Thank you.

OPERATOR

Thank you. At this time, there are no further questions in the queue. I would like to turn the conference over to the management for closing remarks.

Ofer Gonen (Chief Executive Officer)

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

OPERATOR

Thank you. The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.

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