MediWound Q1 2025 Earnings Call Transcript

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May 21, 2025
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Operator

Good day, and welcome to the MediWound First Quarter twenty twenty five Earnings Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Dan Ferry of LifeSci Advisors. Please go ahead.

Dan Ferry
Managing Director at LifeSci Advisors, LLC

Thank you, operator, and welcome, everyone. Earlier today pre market opened, MediWound issued a press release announcing financial results for the first quarter ended 03/31/2025. You may access this press release on the company's website under the Investors tab. I would ask you to review the full text of our forward looking statements within this morning's press release. Before we begin, I would like to remind everyone that statements made during this call, including the Q and 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.

Dan Ferry
Managing Director at LifeSci Advisors, LLC

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 and Hany Luxenberg, Chief Financial Officer. Barry Wolfensen, EVP of Strategy and Corporate Development is also participating in today's call.

Dan Ferry
Managing Director at LifeSci Advisors, LLC

Following our prepared remarks, we will open the call for Q and A. Now, I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer?

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Hey, thank you, Dan, and good morning, everyone. We entered 2025 with strong execution across our clinical, commercial and operational priorities, maintaining the momentum we established in 2024. The value Phase III study for EscharEx is on track, and the addition of a collaboration with Keresys marked a significant milestone, actually bringing nearly all the major wound care companies into our clinical research program. Meanwhile, NexoBrid continues to gain global traction as we advance long term manufacturing investments to support sustained growth. Let's begin with EscharEx, our next generation enzymatic debridement therapy for chronic wounds.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Recruitment for the VALUE Phase III study for venous leg ulcers is progressing as planned. The global trial will enroll two sixteen patients across approximately 40 sites in The United States and Europe. Most of The U. S. Sites are already open, and the majority of the European sites are expected to be activated in the third quarter of twenty twenty five.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Our EscharEx program is strategically de risked, building on the strong results of our Phase II studies. If EscharEx simply replicates those clinical outcomes, the Phase III trial would be considered a clear success with results expected to support both regulatory submissions and commercial positioning. The VALUE Phase III protocol also includes key enhancements designed to further increase the likelihood of success. We have a larger patient population to increase statistical power an interim analysis, 65% enrollment enabling adaptive adjustments this assessment is anticipated in mid-twenty twenty six and we have standardized treatment protocols to minimize variability and ensure consistency across sites. Finally, it is important to note that EscharEx same the same shares the same FDA approved active pharmaceutical ingredient as NexoBrid for nearly identical indication: ESCAR removal.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

To further strengthen our BLA submission and to enhance commercial readiness, we are planning a 45 patient randomized prospective Phase II head to head comparison of EscharEx versus collagenase, scheduled to begin in the second half of twenty twenty five. This study will include both SANTIL and the European collagenase product Iruxol, generating critical comparative data that will be instrumental in supporting our market access and pricing strategies. This quarter also marks a major milestone in our strategic research collaborations. We now have participation by almost all the leading global wound care companies across our clinical development programs. Added to the list is Keresys, which will support our upcoming diabetic foot ulcer trial by providing its tissue product MERIGEN, it is a fish skin graft for active closure.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

With Solventum, Molniki, Kerysis, Mimedix supporting our clinical programs, EscharEx has received strong external validation from most of the key players in the industry. The growing excitement around EscharEx comes from its clear clinical advantages, particularly when we compare it to Santil, the only FDA approved enzymatic debridement agent. This was further reinforced by a recent peer reviewed publication in WOOD, which included a post hoc analysis of our phase two chronic study in VLUs. The data there confirmed EscharEx's superiority across multiple endpoints, including faster debridement, enhanced granulation tissue formation, and improved wound closure. The company has secured the €2,500,000 grant component of the European Innovation Council Accelerator funding to support the clinical and regulatory advancement of EscharEx for the treatment of diabetic foot ulcers.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Following a successful evaluation process, the company engaged in discussions for the €13,750,000 equity investment, which may not be materialized. We don't expect this to impact our time The DFU study remains on track to begin in 2026, pending alignment with both the FDA and EMA on the trial protocol. The rationale for our excitement around the DFU program was clearly demonstrated at recent major international wound care conferences, including the WHS, SAWC, and Yuma. We presented DFU specific data from our first Phase II study of ESCORECT. That study included patients with DFU, VLU, and with trauma wounds, and the DFU results mirrored the strong efficacy we have already seen in VLUs.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

I will mention a few key findings. Esthrax achieved fifty eight percent complete debridement compared to just fourteen percent with a gel vehicle. Stenulation tissue was observed in forty two percent of treated wound versus only eleven percent with a vehicle. The median time to complete debridement was just twenty three days for EscharEx compared to one hundred and twenty eight days with the gel, and the median time to wound bed preparation was twenty four days for EscharEx, whereas it was not achieved at all in the vehicle group. With all this momentum, and assuming positive results from the VALUE Phase III study, we believe EscharEx is well positioned to become the global leader in enzymatic wound debridement.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Now let's turn our attention to NexoBrid, our innovative enzymatic therapy for severe burns. US adoption of NexoBrid continues to expand with consistent ordering from nearly 60 burn centers. Our commercial partner, Vericel, reported a two zero seven percent year over year increase and a 31% sequential increase in NexoBrid revenue during the first quarter of twenty twenty five. In Japan and Europe, demand continues to exceed manufacturing capacity. We remain on track with the commissioning of our new manufacturing facility, with operational readiness expected by year end 2025.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Commercial availability will follow regulatory approvals from the FDA and EMA, and it is anticipated in 2026. This facility will significantly expand our production capabilities, enabling us to meet growing global demand and support sustained revenue growth. NexoBrid also featured prominently in recent scientific and clinical communications. Results from a pediatric Phase III study were published in the peer reviewed journal Burns, reinforcing NexoBrid efficacy and safety as a nonsurgical eschar removal therapy for both adults and pediatric burn patients. At the American Burn Association Annual Meeting, new data were presented on NexoBrid's emergency use during the Israel Hamas war.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

NexoBrid was used to treat patients with blast injuries and complex burns. One hospital reported treating a trauma or a burn patient every minute for twenty four hours, highlighting NexoBrid's vital role in mass casualty and emergency situations. Governments around the world took note of NexoBrid impact. In particular, the U. S.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Government has expressed interest in establishing a domestic backup manufacturing site. In response, we have initiated planning selection for a future US based facility, a project supported by BARDA. We are also seeing increased interest in stockpiling NexoBrid as part of the global emergency preparedness efforts and we believe some of these discussions will translate into concrete opportunities once our manufacturing capacity expands. And now I would like to turn the call over to Hany to review our financial performance in more detail. Hany?

Hani Luxenburg
Hani Luxenburg
Chief Financial Officer at MediWound

Thank you, Ofer, and good morning. Total revenue for the first quarter of twenty twenty five was $4,000,000 compared to $5,000,000 in the first quarter of twenty twenty four. The decline reflects lower revenue from BARDA funded development services as the NexoBrid development program for both adult and pediatric population approaches completion. Gross profit for the quarter was $700,000 representing a gross margin of 19% compared to $600,000 and a gross margin of 12% in the prior year period. This improvement reflects a favorable change in our revenue mix.

Hani Luxenburg
Hani Luxenburg
Chief Financial Officer at MediWound

R and D expenses totaled $2,900,000 compared to $1,500,000 in Q1 twenty twenty four, reflecting continued investment in the EscharEx VALUE Phase III trial and associated development activities. SG and A expenses were $3,100,000 compared to $2,900,000 in the prior year period. Operating loss for the quarter was $5,200,000 versus $3,700,000 in Q1 twenty twenty four. Net loss was $700,000 or $07 per share compared to a net loss of $9,700,000 or $1.05 per share last year. The improvement was primarily driven by non cash financial income related to warrant revaluation.

Hani Luxenburg
Hani Luxenburg
Chief Financial Officer at MediWound

Adjusted EBITDA loss for the quarter was $4,000,000 compared to $2,900,000 in the prior year period. Now turning to our balance sheet. As of 03/31/2025, we had $38,700,000 in cash, cash equivalents and deposits, compared to $43,600,000 at year end 2024. We used $5,100,000 to fund our operations during the quarter. That concludes my financial review offer. Back to you.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Thank you, Hany. So in summary, we began 2025 with strong execution and meaningful progress across our key programs. The VALUE Phase III trial of EscharEx remains on track, supported by growing scientific evidence and engagement of virtually all major wound care players and wound care partners. We are advancing complementary studies to support market access and future commercial success. NexoBrid continues to gain traction globally, with record U.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

S. Sales, high demand in international markets, and new clinical data demonstrating its value in both routine and emergency care. Operationally, we remain focused on scaling our manufacturing capabilities to support long term growth, with the new manufacturing facility progressing on schedule and a U. S. Expansion plans underway.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

With a solid foundation and focused pipeline and strong strategic alliances, we are well positioned to deliver long term value. With that, I will now turn back the call to the operator to open the line for questions. Operator?

Operator

Our first question comes from Chase Knickerbocker with Craig Hallum. Please go ahead.

Chase Knickerbocker
Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC

Good morning and good afternoon. Appreciate you taking the questions. Maybe just first on manufacturing, can you remind us what is kind of yet to be done to kind of be ready for scale up by year end? And then any additional feedback that you've gotten from the relevant agencies around timing of those required regulatory approvals, sign offs, particularly with the FDA? Thanks.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Hi, Chase. Great to have you with us today. Let me address the manufacturing questions. So as I said, the demand for NexoBrid is increasing due to several factors. We have major market launches, US Japan, growing governmental interest, expanding of indications, the pediatric indication, the military use.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

So we are focusing on making sure that we will be able to deliver. We completed the construction of the new facility, and we are now in the commissioning phase. Actually, we are on time, and we anticipate achieving all operational capacity by the end of twenty twenty five. After that, we are calling for inspections, EMA and FDA. EMA is easier because the inspectors are Israelis, so we expect it to be quite sooner.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

As for the FDA, there is quite of an uncertainty about how they are doing remote inspections these days. Anyway, we are expecting that only around mid-twenty twenty six, so we have time.

Chase Knickerbocker
Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC

Got it. And then just on the potential for some U. S. Capacity. Any thoughts on kind of when investors should be expecting kind of movement there, when you we could have seen kind of a a a be identified, you know, something formal with the US government in place, etcetera. You have any thoughts on kind of timing there?

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Yeah. So, as you know, the U. S. Government has expressed interest in establishing such a domestic backup manufacturing site. We have a project that we believe will be finished by Q3 this year.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

After that, we will have the understanding about the location, timing, etcetera. As I said, this project is fully supported by BARDA.

Chase Knickerbocker
Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC

And then you had a number of posters and presentations at SAWC, and I would imagine you had an opportunity to catch up with a lot of, you know, the relevant clinicians at a lot of your sites for the VLU study. Any incremental thoughts from them as far as enrollment goes? Are things kind of to plan as far as what you expected thus far? Anything taking longer or shorter than expected? Just kind of an update on initial cadence of activations and as we look for some initial enrollment progress here in the short term.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Yeah. So since I met you at this conference, so I know that you have been there. So in this conference, MediWound had a very strong performance. Many, many presentations, posters, abstracts were shared. We saw we met the majority of the PIs from The United States, and the excitement is there.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

This trial is the most significant and comprehensive trial in venous leg ulcer patients in the past few decades. This is why all the leading wound care companies and the top KOLs are collaborating with us in this endeavor, because they know that if is success, this trial is going to have a huge impact on the market. So as we said, the recruitment of this study is progressing as planned. We expect the next milestone, the most important milestone, is having the interim data mid-twenty twenty six, and we don't see an issue in getting there.

Chase Knickerbocker
Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC

Thanks, Ofer.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Thank you.

Operator

And the next question comes from RK with H. C. Wainwright. Please go ahead.

Ramakanth Swayampakula
Managing Director at H.C. Wainwright & Co.

Good afternoon, Mofford and Hanif. A couple of quick questions. So in your prepared remarks, you started talking a little bit about stockpiling of NexoBrid. So in general terms, you know, how are you planning for this? I know you have enough demands on you for the product.

Ramakanth Swayampakula
Managing Director at H.C. Wainwright & Co.

So I'm just trying to think in general terms of what could we even be thinking in dollar amounts worth of stockpiling that you could be expected to fill.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

So hi, RK. This is great to have you on the line today. It's a great question. You know, stock currently, we have guidance regarding our revenue. Okay?

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

We can achieve those numbers, and currently our preference is to treat patients, not to use NexoBrid. I don't want it to be in a shelf somewhere. So even governments that we are speaking with, they are familiar with our priority, first of all, to treat real patients, and it will also support great commercial launches in specific territories. As for how much governments will buy in 2026, '20 '20 '7, I can't really give you the numbers. All I can say is everything is embedded in the guidance that we are giving, generating revenue of $24,000,000 this year and generating $30,000,000 to $33,000,000 next year.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

After that, we will know better. I can just share with you that after what countries saw, what NexoBrid did during the Israeli Hamas war, there is a growing interest around many governments United States, Europe, and others, and we are just starting the discussions now.

Ramakanth Swayampakula
Managing Director at H.C. Wainwright & Co.

Thank you for that. So in terms of the EscharEx, the ongoing EscharEx phase three trial, You know, you were saying you have 40 centers running the trial for you. Of the 40 centers, what percentage is in The US and would there be any reason why the study could get completed ahead of time than what you are anticipating right now?

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

So it's an interesting question. We are, first of all, as for the fact, the sites, almost 50% of the sites between 17 to 20 will be in The United States. We have two to three sites in Israel and the rest will be in Europe, so this is the structure of the site. As for enrollment pace, as you can imagine, there are one point five million patients in The United States that are relevant to such a treatment. We chose the most performing sites to participate in the trial, so we don't think that enrollment will be an issue.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Having said that, we spend a lot of energies, a lot of money, and a lot of efforts making sure that we are recruiting the right patients. I don't want a healthy patient to join the study, I don't want someone that a placebo can cure his wound to join the study, I don't want a person that by mistake, by chance know the PI to join the study. So the screening process is something which is very, very articulated. So we plan half a patient per site per month, and this is our track record of clinical trials in this indication. This is what we know from the previous clinical trials that our CRO this is the track record that they have, so we don't see a reason that it will be quicker, and actually we are not in a rush.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

The only thing that we care about is that this trial will be a success and that it will change the treatment of chronic wounds.

Ramakanth Swayampakula
Managing Director at H.C. Wainwright & Co.

And last question from me, Ofer. In terms of the phase two head to head study against collagenous, which you plan to start soon, would the results of that study and the phase three study come around the same time, or one would, the phase two would come ahead of it? Just trying to understand so that, you know, when the whole package will be ready to be, you know, sent off to the regulators.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

The plan is that the trials will finish, I think the head to head study, since it didn't start yet, so I cannot tell for sure, but the plan is that it will be finished ahead of the phase three study. It's a much shorter strategy. We are looking there are all kinds of parameters that will impact especially safety, market aspects, pricing aspects, etc. We don't need the long follow-up, the three month follow-up after the study completes in the phase three trial. So this is much shorter and much and more simpler trial.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

As far as we are planning now, we will get the final results before the phase three is completed.

Ramakanth Swayampakula
Managing Director at H.C. Wainwright & Co.

Thank you. Thank you very much for taking all my questions.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Thank you, RK.

Operator

And the next question comes from Michael Okunwicz with Maxim Group. Please go ahead.

Michael Okunewitch
Senior Biotechnology Analyst at Maxim Group

Hey there. Thank you so much for taking my questions today. Hi, Michael.

Michael Okunewitch
Senior Biotechnology Analyst at Maxim Group

I guess I'd just like to follow-up a little bit on the head to head study, and in particular, if you could help us understand what kind of considerations might go into the pricing strategy. If you're achieving faster deprivement than SANTA with fewer applications, you then justify enhanced pricing to match cost per application? Or then do you also need to consider the reduced health care utilization with faster debridement as well? I'd just like to get a sense of kind of what factors and metrics would be relevant for those pricing determinations.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

So hi, Michael, and thank you for joining us today. Barry, can you please address that question?

Barry Wolfenson
Barry Wolfenson
Executive Vice President of Strategy & Corporate Development at MediWound

Sure, absolutely. Hi, Michael. Good question. Think, you know, the model that we have out right now with our $851 price target is merely the first component that you mentioned, which is what was the cost of the product over the duration of the treatment period. And we're comparing the average cost of Santal over a treatment period versus then what would be the anticipated premium for the average cost of escharEx.

Barry Wolfenson
Barry Wolfenson
Executive Vice President of Strategy & Corporate Development at MediWound

The next part is what we'll be doing, we're actually doing a full market research study on market access and pricing that will get into the second component, which is the HEOR, the health economics component of it. Where we do look at what are all the downstream impacts of saving six weeks of treatment from the time that it takes to apply the drug, the nursing time, the physician time, to what happens to these patients. Do some of them end up in the hospital? Do they have infections that are needed to be treated? And once we get all of that together, if indeed there's a good pot of dollars that the facility would save on average, then we think that we have the opportunity to take a higher premium against SANTL.

Michael Okunewitch
Senior Biotechnology Analyst at Maxim Group

All right, thank you. I really appreciate that additional clarity. And then when thinking about the potential for new stockpiling programs for NexoBrid, would you expect that these would come from your expanded new manufacturing facility, or could there be more agreements similar to The U. S. Domestic program to set up a dedicated manufacturing for those?

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

It's a good question. We are planning to have some flexibilities here. We have the current manufacturing facility. We are going to have available the new scale up manufacturing facility. We are planning a new manufacturing facility in The United States, and we have another facility to support the Department of Defense program, another facility that will be completed by the end of twenty twenty five, actually will be completed this year.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

For many wound, those facilities significantly expand our manufacturing capacity. We don't want to be in a position three years from now launching EscharEx, telling the analysts again, Hey, there is huge demand, but we cannot support that. So those facilities significantly expand our manufacturing capacity and will provide us with critical support to first of all, to a successful launch of EscharEx and to be able to satisfy the demands for all the countries that will be interested in stockpiling.

Michael Okunewitch
Senior Biotechnology Analyst at Maxim Group

All right. So there is expectation that this new US backup manufacturing could be used to help support demand commercially as well, not just stockpiling?

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Yeah. The the current facility that we are that that we are that we are building in Israel is enough to support the demand we anticipate. Adding a facility in The United States can be not only backup, also to expand manufacturing of NexoBrid and maybe to support us with the manufacturing of EscharEx as well.

Michael Okunewitch
Senior Biotechnology Analyst at Maxim Group

All right. Congrats on all the great progress, and thank you for taking my questions once Thank

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

you.

Operator

And the next question comes from Scott Henry with Alliance Global Partners. Please go ahead.

Scott Henry
Managing Director & Senior Research Analyst at Alliance Global Partners

Good day. First question, the NIH funding environment is certainly challenging, which could impact BARDA, Department of Defense. It seems like that revenue was down a little bit in Q1. Are you expecting that to rebound significantly the coming Or how should we think about that overhang, even though that's not a main priority? Obviously, the product sales are more important. Just trying to get a sense of how to model that Development Services line.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

So hi, Scott, and thank you. It's great to having you with us today. Maybe, Hany, do you want to answer this question?

Hani Luxenburg
Hani Luxenburg
Chief Financial Officer at MediWound

Scott. Great to have you with us. Thank you for the question. So our guidance for 2024 remain with no change. Actually, we anticipate $24,000,000 in total revenue.

Hani Luxenburg
Hani Luxenburg
Chief Financial Officer at MediWound

As you all aware, the change in the USA administration caused a brief delay in the approval of both BARDA and DoD funded activity during the transition. However, all programs now appear to be back on track, and we do not anticipate any material impact on our revenue on our 2025 funding outlook. And the outcome is that the revenue will not change for this year.

Scott Henry
Managing Director & Senior Research Analyst at Alliance Global Partners

Okay, great. So it sounds like we should expect that to rebound, if not the second quarter, certainly the second half of the year.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Yes. Let me step here and clarify. In the first sixty days, the administration, they didn't know what they can approve, what they cannot approve, then it was a kind of uncertainty. The feedback that we are getting is everything, at least for our programs, is back on track, and we anticipate the 24,000,000 guidance to remain as it is. And the programs that they are funding as programs with a priority that will keep on getting The U. S. Government funds.

Scott Henry
Managing Director & Senior Research Analyst at Alliance Global Partners

Okay, great. Thank you for that color. And Hany, since I have you there, could you talk a little bit about the below the line, below the operating income, that financial income expense line has been pretty volatile, It's certainly very positive in this quarter, more of a negative not negative, but more of an expense in the prior quarter. How should we think about that below the line expense, financial income expenses going forward? What's a representative number? Is there any noise in there?

Hani Luxenburg
Hani Luxenburg
Chief Financial Officer at MediWound

I wish I knew the representative number. If I knew it, I wouldn't be here because it's very much influenced by our share price in the end of each quarter. The below the line expenses is mainly from the financial income or expenses from revaluation of our warrants. So at the end of each quarter, we are doing a revaluation, and it very much depends on the share price, if it was increased or decreased from the beginning of the quarter, and this set the direction of the income or expense. So, at the end of this quarter, the share price was 15.52, much below what it is now.

Hani Luxenburg
Hani Luxenburg
Chief Financial Officer at MediWound

So it is very much dependent, I cannot tell you what to expect, it depends on the market, and I hope we'll see a good transition in our share price, and it will set the opposite way, because if it increases, there are expenses, financial expenses. If it decreases, there are financial income. I hope I answered.

Scott Henry
Managing Director & Senior Research Analyst at Alliance Global Partners

Yes. And and that's actually quite helpful. I'll just take a look at the filings where I'll get the greater detail. But but that is helpful. Thank you for that, and thank you for taking the question.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

If I may add, those options expire in November 2026. These are $34,000,000 of warrants that are way below the money. If you want to look at next quarter, you will see that there was a significant increase in the share price. Probably there will be financial expenses related to that, but we are okay with that. Hopefully, after November 2026, this company will remain with no warrants, and this issue will be will disappear.

Scott Henry
Managing Director & Senior Research Analyst at Alliance Global Partners

Okay. Great. Thank you for that color.

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Okay. Thank you, Scott.

Operator

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

Ofer Gonen
Ofer Gonen
Chief Executive Officer at MediWound

Okay. So thank you, everyone, for joining our day. We look forward to updating you again in our next quarterly call.

Operator

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

Executives
    • Ofer Gonen
      Ofer Gonen
      Chief Executive Officer
    • Hani Luxenburg
      Hani Luxenburg
      Chief Financial Officer
    • Barry Wolfenson
      Barry Wolfenson
      Executive Vice President of Strategy & Corporate Development
Analysts
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Key Takeaways

  • EscharEx’s VALUE Phase III trial for venous leg ulcers is on track to enroll 216 patients across ~40 U.S. and European sites, with an interim analysis expected mid-2026 and a complementary head-to-head study versus collagenase slated to begin in H2 2025.
  • Strategic collaborations with industry leaders like Keresys, Solventum and others, plus a €2.5M EIC grant, provide strong external validation for EscharEx and support its planned diabetic foot ulcer study in 2026.
  • NexoBrid adoption continues to accelerate globally—U.S. orders rose 207% year-over-year—and MediWound’s new Israeli manufacturing facility is on schedule for operational readiness by end-2025, with commercial availability anticipated in 2026.
  • Real-world emergency use of NexoBrid during the Israel-Hamas war and growing interest from governments have driven discussions on U.S. backup production under BARDA support and broader stockpiling for mass casualty preparedness.
  • MediWound reported Q1’25 revenue of $4M (down from $5M), a net loss of $0.7M, $38.7M in cash, and reaffirmed its full-year revenue guidance of $24M while increasing R&D spend to advance EscharEx trials.
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Earnings Conference Call
MediWound Q1 2025
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