Mediwound Ltd (MDWD) 2026 Q2 法說會逐字稿

Good day, and welcome to the MediWound second-quarter 2026 earnings conference call. (Operator Instructions) Please note this event is being recorded.

I would now like to turn the conference over to Gaia Shamis from LifeSci Advisors. Please go ahead.

Thank you, Chloe, and welcome, everyone. Earlier today, before the market opened, MediWound issued a press release announcing financial results for the second quarter ended June 30, 2026. You may access this press release on the company's website under the Investor tab. I would ask you to review the full text of our forward-looking statements within this morning's press release.

Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to MediWound's expected future performance, future business prospects or future events, or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with the SEC.

In addition, all forward-looking statements represent our views only as of today, and MediWound assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise.

This conference call is 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; Hani Luxenburg, Chief Financial Officer; and Barry Wolfenson, Executive Vice President of Strategy and Corporate Development.

Following our prepared remarks, we will open the call for Q&A.

Now, I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer?

Thank you, Gaia, and good morning, everyone.

During the second quarter, we made meaningful progress against our strategic priorities, advancing EscharEx and expanding the commercial and the development opportunities for NexoBrid.

Specifically, the EscharEx Global Phase III VALUE trial is actively enrolling patients as our assessment of its addressable market continue to grow.

For NexoBrid, Vericel reported its strongest quarter since launch and we entered into a new master service agreement with Vericel following its BARDA contract.

Now, let's start with an update on EscharEx. The VALUE study remains our top priority and our key long-term value driver. Our focus is on execution, with enrollment ongoing, targeting the 216 patients across approximately 40 sites in the United States, Europe, and Israel.

As the study progresses, we are approaching two key milestones, first, the pre-specified interim sample size reassessment, and the second, completion of enrollment, both expected by the end of the first quarter of 2027.

At the same time, we continue to build the broader commercial opportunity for EscharEx. During this quarter, an independent global consulting firm completed an updated US market assessment. Following the expansion of the analysis to include pressure ulcers, this updated assessment now estimates the US annual peak sales at $1.05 billion.

This analysis further strengthened our view that EscharEx across multiple chronic wound indications has the potential to address a substantial market opportunity.

An investigator-initiated study evaluating EscharEx in pressure ulcers is expected to begin in the fourth quarter of 2026.

Our collaboration network across the program now spans essentially all the major relevant advanced wound care companies, including Coloplast, Convatec, Essity, Mölnlycke, Solventum, B. Braun, and MIMEDX.

Together, with the continued progress of the VALUE and the expanding clinical and commercial opportunity, this positions EscharEx as a non-surgical, optimally effective debridement therapy for chronic wounds.

Turning to NexoBrid. The US commercial trajectory continues to strengthen. Vericel reported NexoBrid's strongest quarter since launch with record quarterly revenue, hospital unit sales, and ordering centers. Approximately 80 burn centers have ordered NexoBrid since launch, reflecting continued adoption and increasing utilization across the US burn care market.

Following Vericel's 10-year contract with BARDA, valued at up to $197 million, we entered into a master service agreement with Vericel covering NexoBrid and next-generation product development activities.

Under the MSA, we expect to begin recognizing revenue in the second half of 2026 through participation in development initiatives, including a next generation program launched to support the potential expansion of NexoBrid for use in blast- and friction-related injuries, leveraging real-world evidence.

We continue to advance a room temperature stable formulation of NexoBrid as a non-surgical debridement solution for battlefield burn care, supported by non-dilutive funding from the Department of War with a total program budget of $18.3 million.

Together, these programs further expand NexoBrid's role in burn care, national preparedness, military medicine, and mass casualty response. To support current and future demand, we continue to advance our expanded NexoBrid manufacturing facility. We are implementing the modification requested by the EMA following the pre-audit and expect to complete this work during the fourth quarter of 2026.

Commercial supply from the expanded facility remains subject to regulatory approval and is expected in the second half of 2027.

With that, I will turn the call over to Hani.

Thank you, Ofer, and good morning, everyone.

Turning to our financial results for the second quarter of 2026. Revenue for the quarter was $3.1 million compared with $5.7 million in the second quarter of 2025. The decrease primarily reflected the timing of BARDA-funded development revenue.

Gross profit was $0.3 million, representing a gross margin of 10.9% compared with gross profit of $1.3 million or 23.5% in the prior year period. The lower margin primarily reflected a one-time impact related to the facility scale-up.

Research and development expenses were $5.9 million compared with $3.5 million in the second quarter of 2025, primarily reflecting increased investment in the EscharEx VALUE Phase III trial.

SG&A expenses totaled $3.9 million compared with $3.6 million in the same period last year.

Operating loss was $9.5 million compared with $5.7 million in the second quarter of 2025.

Net loss was $7.4 million or $0.57 per share compared with a net loss of $13.3 million or $1.23 per share in the prior-year period. The year-over-year change primarily reflected non-cash financial income.

Adjusted EBITDA loss was $8.3 million compared with a loss of $4.5 million in the second quarter of 2025.

Turning to our first-half results. Revenue for the first half of 2026 was $4.6 million, compared with $9.7 million in the first half of 2025, primarily reflecting the timing of BARDA-funded development revenue.

Gross profit was $0.7 million, representing a gross margin of 14.4% compared with gross profit of $2.1 million or 21.5% in the prior-year period.

Research and development expenses were $11.1 million compared with $6.4 million in the first half of 2025. Primarily reflecting increased investment in the EscharEx VALUE Phase III trial.

SG&A expenses totaled $7.5 million compared with $6.6 million in the same period last year, primarily reflecting higher professional services costs and exchange rate effects.

Operating loss was $17.4 million, compared with $10.9 million in the first half of 2025.

Net loss was $10.3 million or $0.80 per share, compared with a net loss of $14 million or $1.30 per share in the prior-year period. The change primarily reflected non-cash warrant revaluation income of $7.7 million in 2026 compared with a non-cash warrant revaluation expense of $2.4 million in 2025.

Adjusted EBITDA loss was $15.3 million, compared with a loss of $8.5 million in the first half of 2025.

Now, turning to our balance sheet. As of June 2026, we had approximately $36 million in cash equivalents and deposits, compared with $54 million at year-end 2025. Cash burn during the first half of 2026 totaled $20 million.

Warrant and option exercises generated $0.8 million during the first half, and we received an additional $1.1 million after quarter end.

This concludes my review of our financial results. Ofer, back to you.

Thank you, Hani. The second quarter strengthened both our core growth platform.

The VALUE Phase III program of EscharEx continues to advance toward important milestones. While the updated market assessment and planned diabetic foot ulcer and pressure ulcer studies broaden its long-term clinical and commercial opportunity.

NexoBrid continues to gain commercial traction in the United States. At the same time, the MSA with Vericel, the broader BARDA framework, the DoW funding, all that creates meaningful government-backed product supply and development opportunities.

Our revenue profile remained weighted toward the second half of 2026, reflecting the expected timing of contributions from the MSA and other government-funded programs. Based on these expected contributions, we are reaffirming our full-year 2026 revenue guidance of $24 million to $26 million.

Our priorities for the remainder of the year are clear: continue executing the VALUE trial, begin recognizing revenue under the Vericel MSA, advance our next-generation NexoBrid programs, and complete the EMA-requested modification at our expanded manufacturing facility.

We remain focused on disciplined execution across our strategic priorities and on building durable long-term value across our pipeline.

Operator?

(Operator Instructions) RK Ramakanth, H.C. Wainwright.

Thank you. This is RK from H.C. Wainwright. Good afternoon, Ofer and Hani. Hope you guys are doing well. Lots of stuff going on here. So let's start off on the value study itself.

On the study, do you still plan to get the study enrollment completed and get the interim also done during the early 2027? That's my first question.

The second one within that is very recently. Smith & Nephew on their call, they were talking about potentially working on a second-generation SANTYL. I'm not sure you folks are aware of it. And what do you think? What's your business intelligence on that molecule? And how does that impact EscharEx development from here onwards?

Excellent. So hi, RK, and thank you for joining. The first question is a short answer. Yes, our target of meeting the interim assessment and the enrollment completion is still in the first quarter of 2027.

As for the second question regarding Smith & Nephew's approach to potential competition from EscharEx, maybe Barry, do you want to take this one?

Sure, absolutely. Hi, RK. We heard those comments and we found them interesting. I think the thing that's most notable about the comments were the context where he was talking a little bit about, someone asked him about the competition. He was talking a little bit about his thoughts around EscharEx, but then he said that they noted that SANTYL is not a fast debridement option, that it is slow. And because of this, that's what's driving their desire to make this second-generation product.

It's actually being developed by a company that they've invested in called Certa Therapeutics. The molecule is SN or the drug, I should say, is SN514. Based on all the publicly available information we've been able to see, we're not aware of this drug having entered into any clinical development in chronic wound patients. We see some activity around burns, but not.

Chronic wounds. And so while we take any potential competition seriously, EscharEx, as is already in Phase III in chronic wounds, and that gives us what we believe to be a substantial clinical lead.

Thanks for that, Barry. So now, based on those comments, does that mean that the market is bigger than what it is because SANTYL is obviously not the molecule of choice if it is not really doing what it is expected to do.

And then the second part of that is on the -- your team has added treasure outsourcing to the pool now. So how is that study being conducted in the sense, what is your responsibility within that IIT? And would that data be available by the time you're ready to file your own application with the agencies, both in the US and in the EMA.

So Barry, maybe you will answer the first part of the question regarding Smith & Nephew and the market for pressure ulcers and I'll speak about the study, okay.

Yes. Well, I think even more broadly, what I think I heard you ask, RK, is does that mean that since SANTYL is not particularly effective and that Smith & Nephew is motivated to create a new drug. The inference is that the market is even bigger than what SANTYL is currently supplying, and we believe the answer to that is resoundingly yes.

That's why, even before including pressure ulcers, we showed our peak sales in the $800 million range and with including pressure ulcers, it tops $1 billion. We believe that a drug for debridement that can reach complete debridement, certainly within four to five days, changes the entire expectation with regard to enzymatic debridement.

It fits better into the workflows of wound clinics and podiatry offices, and it takes away, because of that, utilization share, not just from sharp debridement, but across all different modalities. So we do believe that it greatly expands the market.

So if we speak about the pressure ulcer study, so it's important to mention that the Phase III VALUE study in VLU, this is the primary focus of EscharEx development program. It's of course the company's key value driver.

The pressure ulcer study is an investigational initiative. It's not run directly by us.

It's a small study, open-label trial, 10 to 15 patients, and the initiation is expected in the fourth quarter of 2026. It involves, of course, pressure ulcer patients. All of them are treated with EscharEx across a week or two. And we are assessing, as usually, debridement, granulation, and wound closure.

Following this -- the VALUE readout, we plan to approach with the FDA and determine what would be required to pursue approvals also for DFUs and pressure ulcers.

Thank you. One last question. This is on NexoBrid. So it's a two-part question. The first one. What is EMA requesting you to do in terms of the new plant, and at least on the outset, it looks like timelines are moving back, so is that true in your sense of the world and also.

If things get pushed to fourth quarter of '27, does that mean the real product for the market actually gets pushed into 2028? And the third part of the questions are on the CPT code, where do we stand and is January 2027 still an effective and realistic date?

So I will address the manufacturing facility question. I think there was a confusion. As I said in the call, we completed the EMA pre-audit process, and they recommended some operational changes that we are about to complete in the fourth quarter of this year, not the fourth quarter of 2027. So we'll complete all the implementation.

The feedback that we got was operational in nature, not related to product quality, safety, or comparability concerns, which is very important.

Once this work is complete, we will begin the manufacturing of NexoBrid in the new facility and then following submission, review and inspection. We can get approval as early as in the second half of 2027. So we have a delay. We reported this last quarter, but we are currently on track.

As for your second question, the CPT code, Barry, do you want to address it?

To my knowledge, there is no publicly available information regarding any update on to a Category I CPT code.

Okay. Thank you. Thanks for taking all my questions.

Thank you.

Josh Jennings, TD Cowen.

Hi, good morning, Ofer, Hani, and Barry. Thanks for taking the question. I wanted to just touch on the updated MSA with Vericel. Can you just any additional details you can share just on changes to revenue recognition is the major update that you'll be recognizing of revenue for the development program that's been expanded for blasts and friction injuries and potentially extending the shelf life of NexoBrid.

And then the second question is just on any updates to the path for the DFU indication in the clinical development program there. Thanks for taking the questions.

Hey, Josh. Good to speak to you. So, let me speak about the BARDA economics and its strategic importance. So, as mentioned in April, Vericel was awarded a 10-year contract that is valued at up to $197 million. It is covering procurement, vendor-managed inventory, US-based manufacturing readiness, next-generation formulation development, and the potential blast and trauma expansion.

It's a large, it's a multiyear framework agreement with several components, so I understand the appetite for more precision.

We are currently not in a position to share additional detail. It reflects confidentiality obligations to Vericel, as well as the fact that several elements of the program remain subject to further FDA feedback, which could affect the scope of development and work required.

What is concrete today is that the MSA signed the first development program, the blast and friction injuries, is underway, and Vericel expects about $6 million of BARDA procurement revenue in the second half.

Additional elements, including the room temperature stable formulation, the US-based manufacturing readiness, these are areas that we are now in discussions with Vericel and BARDA regarding the scope, timing, technical requirements, and potential implementation pathway. So this is the maximum we can share right now.

And as I said, we are about to begin recognizing revenue from that program in the second half of 2026.

If this is good enough, I'm moving to the DFU.

Thank you. Thank you, Ofer. That's great.

Okay. So regarding the DFU, we have constructive discussions with the FDA and EMA. We got feedback. We are aligned on the DFU.

Protocol, you can see the highlights of the protocol; it is attached to our corporate deck, and we plan to initiate the study in the fourth quarter of 2026.

This Phase II DFU study is expected to enroll 50 patients. It's a randomized trial, one-to-one design, EscharEx versus placebo.

And the primary endpoint is something that EscharEx is very good at, time to complete debridement, so we see it as a trial which is not that complicated.

As I said to the previous question that I asked by RK, we plan to approach the FDA after the VALUE readout and then to determine what would be required to pursue approval for that indication as well.

Thanks for those answers.

Jeff Jones, Oppenheimer.

Good afternoon, Ofer, and thanks for taking the question. One point of clarification on the BARDA contract with Vericel. You noted that Vericel is planning to receive $6 million in BARDA revenue in second half. How then does that align with the $14 million to $15 million in BARDA revenue that you guys are projecting for 2026. Is that dependent on some of these other pieces that are under negotiation?

And then in regards to NexoBrid, looking ahead into '26 and '27, how do we think about revenue given the facility now doesn't look to be coming online until second half '27?

Okay. Hi, Jeff. Good to have you on. So as for the first question, you gave there a number that I'm not familiar with, which is the $14 million. The $14 million is not exclusively by BARDA.

We have additional government-related agreements, one of them you're familiar with, which is the Department of War, so expect some use there as well. The MSA agreement includes a few components.

As I said, I cannot give you at this stage due to confidentiality obligations. I cannot give you all the components. Having said that, the first program which is development of a blast and friction burn indication is on its way. Additional components are currently discussed and negotiated.

As for the procurement, MediWound expects to benefit from the procurement that BARDA has with Vericel. It's not one-to-one. We have the prices with Vericel, nothing really is disclosed at this stage. But when you speak about the amount of development services about the agreement, it contains a few components and not only one.

Great, thank you.

This is the first sentence, the first question. As for the second question, Hani, do you want to address the manufacturing facility delay?

So hi, Jeff. We do not actually expect the current facility timeline to have material impact on our 2026 revenue guidance.

Importantly, meaningful portion of the revenue we expect in the second half is associated, as with government-funded development activity and product supply under existing agreements, rather than being depending on commercial supply from our expanded facility. So our $24 million to $26 million in 2026 revenue guidance already reflect the current status and expected timing of our facility.

And as you asked also about '27 and '28, as I mentioned earlier about facility readiness, our plan is to finish all the modification by the end of the fourth quarter of this year. And first thing that we are going to do next year is to start manufacturing NexoBrid, so we don't think there will be any impact at all to the expected revenue in '27 and '28 for NexoBrid.

Thank you, guys, very much.

Chase Knickerbocker, Craig-Hallum.

Thanks for taking the questions. Maybe just on a little bit more specifics about VALUE, can you just talk about how the enrollment rate has trended sequentially on like a per site basis? And then can you just confirm that kind of all those 40 sites are up running and enrolling?

And then just as we think about what your expectation for the 1Q resampling is, are you assuming any improvement in enrollment trends in that assumption or is it just kind of static?

Hey, Chase. Good to have you with us. As for the VALUE, let's speak about the numbers. To protect the integrity of the study, we cannot show patient enrollment numbers or enrollment trends during the conduct of the study in multinational study. Individual snapshots can be noisy, and the advice we're getting is not to share any information.

We think the more useful commitment is the milestones. It's the interim assessment and the enrollment completion.

What can I say now is that the design hasn't changed, 216 patients, roughly 40 sites, and we expect the interim sample size reassessment and enrollment completion to be by the end of the first quarter of 2027. We do not need any improvements or changes in trends. We are on track.

I hope I answered the first question right.

Yeah, and maybe can -- I mean, you've spoken to kind of active sites in the past. Can you maybe just speak to kind of the update there? And then -- go ahead.

But regarding the sites, as we said, we are targeting approximately 40 sites and we are something like very close to have them all recruiting. We have less than 10% to reach this target.

Got it. Nd then maybe just as we think about, you obviously are also guiding to full enrollment, but if we just think about top-line data post-last patient enrolled, I mean, should we think about it as kind of 12 weeks, obviously to that wound healing follow-up? And then kind of a month or two for data lock and the like, or maybe just talk us through exactly how that timeline will work.

And then lastly, just one for Barry. So we're seeing a pretty large volume shift in wound care from site 11 to site 22. Can you just remind us the sites of service that you think EscharEx will predominantly be used in if approved?

And then if you could just remind us again where kind of SANTYL usage is concentrated today, and how you expect that to kind of change from a mixed perspective for EscharEx. Thanks.

So Barry, let me start with answering about the clinical trial, if this is okay. Well, you plot it quite accurately, Chase, our plan is to have the interim assessment by the end of Q1. If everything goes well, it takes another quarter or so to get the top-line data. And after the top-line data, it is another few months until the final results.

As for EscharEx, Barry, do you want to address it?

Sure. Most of that shifting, of course, Chase, has to do with the CMS change to how it reimburses the tissue substitute products. Based on the third-party data that we've acquired regarding prescriptions of sample, it's fairly well distributed across acute care into clinics, into home health, and certainly, into nursing homes and SNFs. And we don't see that materially changing, nor do we see that being any different for EscharEx.

Thanks, guys.

Michael Okunewitch, Maxim Group.

Hey, guys. Thank you for taking my questions today.

So I just I wanted to follow-up on the question surrounding the '27 revenues and particularly to understand mechanically how that works with your current projections since it's nearly a doubling of the NexoBrid-specific revenues that you are projecting. So is this a case where there's pent-up demand that would lead to a surge in sales in the fourth quarter once you get that approval? Or can you actually ship the product and recognize revenue before the second-half EMA commissioning?

Hi, Michael. This is a good question. So as I said, we are actually manufacturing the NexoBrid at the beginning of 2027. Everything is ready to be shipped. The demand is there.

Second half of 2027, we can sell significantly more than we are selling now. Currently, as our ability to sell is capped by manufacturing capabilities and in 2027, this limitation will finally be removed.

And then how does the delay on the EMA side effect FDA? Is that still one half after EMA approval or would these now be contemporaneous?

Mathematically, it's something like three months. Having said that, the most important milestone is getting the first approval. As I mentioned in the previous call, and I'm sure that you remember, EMA comes first.

And once EMA comes first, we can start selling substantially most of the inventory to the European countries. And then the current facility can be dedicated to sell to the US market and to stockpile for governments.

So this is the more important milestone. So this is why we're speaking about the first regulatory approval. If FDA happens three months after that or five months after that depends on inspections and other things, I don't think it will really change anything from a revenue point of view.

Thank you. And then one last one for me before I hop back into the queue. In the second half of this year, you are expecting quite a significant uptick in revenues, particularly from development services, well beyond what you've seen historically, even when you had the full BARDA contract up and running. So I wanted to understand what's going to be driving that. Is that primarily the new programs that have been announced taking effect or is this some front-loading to the new BARDA contract you signed after the lapse?

Yes, you're right, we are reaffirming the $24 million to $26 million revenue guidance for 2026. Since the revenue for the first half was $4.6 million, clearly the majority of the year, it is weighted toward the second half of the year.

We expect meaningful step up in second half, driven by the product supply related to the contracts, development services under the Vericel MSA and other government-funded programs, including the Department of War and, of course, the ongoing commercial NexoBrid sale.

Under the MSA, we just announced that we initiate the first development program to support the expansion to blast injuries.

But we, as I mentioned, we expect to initiate additional development programs under the MSA in the near term as well.

All right. Thank you. I appreciate the additional color here.

Thank you, Michael.

Scott Henry, Alliance Global Partners.

Thank you and good morning or afternoon, depending on your location. Most of my questions have been asked, but I did want to follow-up on the product sales for 2026. Obviously, the $2.6 million was very strong in 2Q, but first quarter was only $528,000.

Based on what I got out of the filings, would it be better to think about capacity for product sales as kind of the combination of those two, so about $1.7 million to $1.8 million per quarter? Is that kind of how much you can make in a quarter until we get this capacity? Is that how I should be thinking about it, or could you duplicate $2.6 million again prior to the capacity expansion? Thank you.

Hi, Scott. As we are not guiding specifically for products, but I don't think it will be the right thing to do is to think that we sold everything that we could. Again, we are capped only by capacity, not by demand.

The inventory of NexoBrid is currently zero, I think, in the most territories and definitely here in the facility. Some of the impacts that you saw that prevented us to generate more revenue were because of the fact that the facility itself needed to go through all kinds of inspections and all kinds of upgrades, et cetera. So I think it would be more accurate to look at the second quarter.

Having said that, I would look at last year and we are selling everything that we have. So maybe last year, if you add, let's say, 10% premium because of price changes and a little bit more effectiveness, I think it will be more accurate.

Thank you for the color. That is helpful. And then perhaps a question for Hani. R&D, should we expect a significant spike still in the second half of 2026? How should we think about the next couple of quarters there? Thank you.

Hi, Scott. The increase in R&D is primarily driven by our VALUE Phase III trial, which remains our top strategic priority in the company. We are not providing quarterly R&D guidance, but we are currently at an elevated level of investment and expect R&D spending to remain elevated as VALUE progresses through this phase of our program.

At the same time, a meaningful portion of our NexoBrid development activity is supported by non-dilutive government funding through BARDA and through the Department of War.

So while we are investing significantly in VALUE, we are also being very disciplined about where we deploy our own capital. I hope I answered your question.

Okay, great. Thank you for that feedback. And thank you, both, for taking the questions.

Thank you, Scott.

This concludes our question-and-answer session. I would like to turn the conference back over to Ofer Gonen for any closing remarks.

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

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