MediWound Q2 2025 Earnings Report

MediWound EPS Results

• Actual EPS: -$1.23
• Consensus EPS: -$0.55
• Beat/Miss: Missed by -$0.68
• One Year Ago EPS: N/A

MediWound Revenue Results

• Actual Revenue: $5.71 million
• Expected Revenue: $5.68 million
• Beat/Miss: Beat by +$31.00 thousand
• YoY Revenue Growth: N/A

MediWound Announcement Details

• Quarter: Q2 2025
• Date: 8/14/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, August 14, 2025
• Conference Call Time: 8:30AM ET

MediWound (NASDAQ:MDWD), a biopharmaceutical company, develops, manufactures, and commercializes novel, bio-therapeutic, and non-surgical solutions for tissue repair and regeneration in United States, Europe, and internationally. It markets NexoBrid, a biopharmaceutical product for the removal of eschar, a dead or damaged tissue in adults with deep partial- and full-thickness thermal burns to burn centers and hospitals burn units. The company also develops EscharEx, which has completed Phase II clinical trials for the debridement of chronic and other hard-to-heal wounds; and MW005, which is in phase I/II for the treatment of low-risk basal cell carcinoma. MediWound Ltd. was incorporated in 2000 and is headquartered in Yavne, Israel.

MediWound Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: EscharEx VALUE Phase III trial is actively enrolling across 40 sites in the U.S. and Europe with new collaborations (ConvaTec, SCT) and an interim sample size assessment expected by mid-2026.
• Positive Sentiment: NexoBrid saw 52% year-over-year revenue growth in Q2 U.S. sales, with manufacturing scale-up on track for completion by year-end and additional BARDA/DoD funding of $3.6 M for a room-temperature stable formulation.
• Neutral Sentiment: Q2 revenue rose 43% sequentially to $5.7 M with gross profit up to 23.5% of sales, though net loss widened to $13.3 M ($1.23/share) largely due to non-cash warrant revaluations.
• Positive Sentiment: Cash and equivalents of $32.9 M as of 6/30/25, plus potential $32 M from in-the-money warrant exercises, are expected to fund operations through upcoming strategic milestones.
• Negative Sentiment: R&D expenses increased to $3.5 M and SG&A to $3.6 M in Q2, driving an operating loss of $5.7 M versus $4.5 M a year ago due to higher clinical and share-based compensation costs.

Presentation

[Operator]

Good day, and welcome to MediWound second quarter twenty twenty five earnings conference call. All participants will be in the listen only mode. 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, premarket open, MediWound issued a press release announcing financial results for the second quarter ended 06/30/2025. 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. 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 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 Ofergonen, Chief Executive Officer of MediWound and Hany Luxenberg, Chief Financial Officer.

[Dan Ferry, Managing Director at LifeSci Advisors, LLC]

Barry Wolfferson, EVP of Strategy and Corporate Development is also participating in today's call. 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, CEO at MediWound]

Hi. Thank you, Dan, and good morning, everyone. In the second quarter, we continued to execute across our clinical, commercial and operational objectives. The EscharEx VALUE Phase III trial is actively enrolling patients, and with new collaboration established with ConvaTec and SCT, all the relevant global wound care leaders are now engaged in our clinical programs. At the same time, NexoBrid continues to gain traction in The U.

[Ofer Gonen, CEO at MediWound]

S. Market, and the commissioning of our manufacturing scale up remains on track for completion by year end. As a result of these activities, we are in a strong position to achieve several key milestones over the next twelve months that are expected to advance our strategic and financial objectives. Now let's begin with an update on EscharEx, our late stage asthmatic debridement therapy for chronic wounds. Enrollment in the VALUE Phase III study for venous leg ulcers is actively progressing This global trial aims to enroll two sixteen patients across 40 sites in The United States and Europe Once sixty five percent of those patients have completed treatment in the VALUE trial, we will perform an interim sample size assessment.

[Ofer Gonen, CEO at MediWound]

We expect this readout to take place by mid-twenty twenty six. During this quarter, we further strengthened our network of research partners. We established new collaborations with SIT and ConvaTec to support both the ongoing VLU trial and the planned DFU trial. Specifically, SCT's JOBS medical compression therapy products are now included in the VALUE trial protocol and ConvaTec's aqua cell dressings will support the DFU study. Both of these category leading partnerships complement our current relationships with Solventum, Molnicki, Keresys, Mimetics and reinforce the broad validation of escharEx within the wound care ecosystem.

[Ofer Gonen, CEO at MediWound]

In addition, a new post hoc analysis from our earlier Phase II study was published yesterday in Advances in Wound Care. It's a leading peer reviewed journal. The analysis confirms that wound bed preparation is a key predictor of healing in venous leg ulcers, and that without it, chronic wounds rarely heal. Wounds that failed to achieve wound bed preparation had a ninety percent probability of not healing in the study, while achieved those it were four times more likely to close. P value was 0.0004.

[Ofer Gonen, CEO at MediWound]

These data validate EscharEx' potential to improve healing outcomes by accelerating wound bed preparation, which is the primary endpoint of our Phase III study. While wound bed preparation has been recognized for nearly two decades as a core principle in chronic wound healing, this is the first time that this concept has been confirmed with a robust clinical evidence. Now let's turn our attention to NexoBrid, our innovative enzymatic therapy for severe burns. In The United States, adoption continues to expand. Our partner Vericel reported 52% year over year revenue growth for NexoBrid in the second quarter, driven by increases in both hospital unit orders and number of ordering centers.

[Ofer Gonen, CEO at MediWound]

Operationally, the commissioning of our new manufacturing facility remains on track towards completion by year end, with regulatory authority review and approval determining the timing of enabling the commercial output. Capacity expansion is critical for us in order to support our global growth. We also continued planning for future U. S.-based manufacturing as part of our collaboration with BARDA. In parallel, we were awarded an additional $3,600,000 in non dilutive funding from the U.

[Ofer Gonen, CEO at MediWound]

S. Department of Defense to support the development of a room temperature stable formulation for NexoBrid, bringing the total program funding to $18,200,000 This supplementing funding will enable expansion of our CMC activities, enhancement of in house manufacturing capabilities, and initial preparations for the clinical trial. Now I'd like to turn the call over to Hany to review our financial performance in more detail. Hany?

[Hani Luxenburg, CFO at MediWound]

Thank you, Ofer and good morning everyone. Let's turn to our financial results for the 2025. Second quarter revenue grew 43% sequentially and also increased year over year. The growth reflects higher product sales and more favorable revenue mix. Total revenue was $5,700,000 up from $5,100,000 in the 2024.

[Hani Luxenburg, CFO at MediWound]

Gross profit for the quarter was $1,300,000 or 23.5% of revenue compared to $400,000 or 8.8% in the prior year period. The margin increase reflects a more favorable revenue mix. Research and development expenses were $3,500,000 compared to $1,900,000 in the 2024, driven by continuing investment in the EscharEx VALUE Phase three study. SG and A expenses totaled $3,600,000 versus $3,000,000 last year, primarily due to increased share based compensation. Operating loss was $5,700,000 compared to $4,500,000 in Q2 twenty twenty four.

[Hani Luxenburg, CFO at MediWound]

Net loss was $13,300,000 or $1.23 per share compared to a net loss of $6,300,000 or $0.68 per share in the same period last year. The increase was mainly driven by $6,600,000 in non cash financial expenses in the 2025, reflecting the revaluation of our warrants. Adjusted EBITDA loss was $4,500,000 compared to $3,400,000 in the 2024. Looking at our performance for the first half of the year, total revenue was $9,700,000 compared to $10,000,000 in the 2024. The slight decrease was primarily due to lower BARDA funded development revenue as NexoBrid R and D program nears completion.

[Hani Luxenburg, CFO at MediWound]

Gross profit was $2,100,000 or 21.5% of revenue compared to 1,100,000 or 10.5% in the prior year period. R and D expenses rose to $6,400,000 from $3,400,000 last year, driven by clinical investment in the Es charEx. SG and A expenses were $6,600,000 compared to $5,900,000 in the same period of 2024. Operating loss for the first half was $10,900,000 compared to $8,200,000 last year. Net loss for the period was $14,000,000 or $1.3 per share versus $16,000,000 or $1.73 per share in the prior year period.

[Hani Luxenburg, CFO at MediWound]

Adjusted EBITDA loss was $8,500,000 compared to $6,200,000 in the 2024. Now, turning to our balance sheet. As of 06/30/2025, we had $32,900,000 in cash, cash equivalent and deposits, compared to $43,600,000 at year end 2024. During the first half of the year, we received $700,000 from the exercise of Series A warrants and used $11,900,000 to fund our operations, including $2,300,000 in CapEx, primarily related to our new manufacturing facility. An additional $1,800,000 in warrant exercise proceeds was received after the quarter end.

[Hani Luxenburg, CFO at MediWound]

As of today, the exercise of outstanding Series A warrant could provide us with up to $32,000,000 in proceeds. These warrants have an exercise price of $13.47 per share and may exercise through November 2026. We believe our current cash position, together with potential proceeds from deals in the money warrant, provide us with the financial flexibility to advance our key program and support operational needs through upcoming milestones. That concludes my review of the financials. Ofer, back to you.

[Ofer Gonen, CEO at MediWound]

Thank you, Jaime. To close, the 2025 reflects disciplined execution in line with our strategic priorities. We remain focused on three core objectives: advancing the EscharEx VALUE Phase III trial towards enrollment targets completing commissioning of our expanded manufacturing facility to meet anticipated demand and building global recognition of escharEx through clinical collaborations and peer reviewed publications. Progress across these areas is on track, positioning MediWound for a meaningful milestone in the months ahead. With that, I will now turn the call back to the operator to open the line for questions. Operator?

[Operator]

Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touch tone phone. 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 questions, The first question comes from the line of Josh Jennings with TD Cowen. Please go ahead.

[Joshua Jennings, Managing Director at TD Cowen]

Hi. Good morning, Ofer, Hani and Barry. It was great to see the post hoc analysis from the ESCRACS Phase two trial published. And I wanted to just, I mean providing another strong signal for success and value. But I wanted to just check-in and see are there any other publications that we should have on our radar that are coming up in the back half of 2025 or into 2026?

[Joshua Jennings, Managing Director at TD Cowen]

And then also just wanted to an update on the head to head trial versus Santal and just making sure that that's still on the docket for this year to kick off.

[Ofer Gonen, CEO at MediWound]

Hey, Josh, it's great to have you with us, as always. Addressing your first question regarding publications, indeed, there are a few other publications that we are not discussing at this stage, but the focus will turn towards diabetic foot ulcer trials. We have data about that. Our motivation here is to gain a lot of appetite across relevant KOLs before we start the trial. There are some very important conferences, the FCON, SAWC, that are upcoming.

[Ofer Gonen, CEO at MediWound]

I would expect to see additional publications around those conferences. As for the head to head trial, we are launching a randomized study at the 2025 to compare EscharEx directly to collagenase. This trial is on track. Our plan is to enroll 45 VLU patients and to split them between EscharEx, placebo, and Santyr or Eruxol in Europe. Yes, this is still our plan.

[Joshua Jennings, Managing Director at TD Cowen]

Excellent. And, you know, BARDA seems to be stepping up. I was hoping you could just give us a review. I know you've done this in the past but just of The U. S.

[Joshua Jennings, Managing Director at TD Cowen]

Facility and BARDA funded you know planning and design. Maybe just help us I guess remember or just better understand the funding there. Is it fully funded? Will MediWound have control of that manufacturing facility once it's completed? Maybe just review the details there, and then I have another follow-up question on BARDA interactions too.

[Ofer Gonen, CEO at MediWound]

Okay. This is definitely an important topic for us. So governments around the world took note of NexoBrid impact during the Israel Hamas war. In particular, the U. S.

[Ofer Gonen, CEO at MediWound]

Government showed interest in a domestic backup site. Apparently, they are not interested in being dependent on manufacturing in Israel. So we started planning and site selection in The United States. The funding of this process is 100% done by BARDA, and we are now getting ready for the second part. Once we know the prices, the cost, location, we can discuss with The U.

[Ofer Gonen, CEO at MediWound]

S. Government the funding of the facility as a whole. I hope I answered the question.

[Joshua Jennings, Managing Director at TD Cowen]

You did, thanks. And BARDA has also published an RFP request for proposal for enzymatic debridement products for treatment of deep and full thickness severe burn injuries. Just maybe just review the elements of that RFP and any progress and how you expect that to play out for MediWound and then the NexoBrid franchise. Thank you.

[Ofer Gonen, CEO at MediWound]

Yeah. So around BARDA, again, they issued just recently an RFP that's covering three major elements, stockpiling of NexoBrid, room temperature stable formulation for nonsurgical debridement agent, and trauma and blast injury solutions. The program is expected to start in the 2025, and it's a contract that should be for ten years. As Vericel disclosed in the last earnings call, they have initiated an RFP process. Where we sell they hold The U.

[Ofer Gonen, CEO at MediWound]

S. Commercial rights of NexoBrid, so they're the leader in this effort in The United States. Of course, as many want, since we have a lot of interest in that, we are providing full support. Hopefully, in the next quarter's call, we will be able to elaborate further about the outcome.

[Joshua Jennings, Managing Director at TD Cowen]

Thanks so much. Appreciate it.

[Ofer Gonen, CEO at MediWound]

Thank you.

[Operator]

Thank you. Next question comes from the line of Maya Eskandarani with H. C. Wainwright. Please go ahead.

[Maya Iskandarani, Equity Research Associate - Biotechnology at H.C. Wainwright & Co., LLC]

Hello, folks. Congrats on the progress this quarter. My question is with respect to the addition of a new compression method for the Phase III value trial. So I believe that brings the total up to five. Can you explain how you plan distribute these, which is the physician's choice of compression method across the two sixteen patients? Thank you.

[Ofer Gonen, CEO at MediWound]

Hi, Maya, and thank you for joining the call. Barry, can you step in and address that?

[Barry Wolfenson, EVP - Strategy & Corporate Development at MediWound]

Sure, of course. Hi Maya, good question. Actually, the FDA in these wound healing studies always look for a follow-up period after the wounds have come to complete closure, just to assess the durability of that closure. So these medical compression therapy products from Essity will be used for that subsegment of patients that have come to complete closure. And what we wanted to do, as we've done with the rest of the products, is to standardize it so that all the patients are getting the same level of treatment.

[Barry Wolfenson, EVP - Strategy & Corporate Development at MediWound]

And so Essity, one of their big lines is JOBST, It's one of the leading lines of medical compression therapy. And we're actually using two different versions of it. One is a custom product depending on if the patient has very particular and oddly shaped legs, and the other one is a more standardized product. But it'll be just for those patients that are in that have come to complete closure throughout the trial and are in that follow-up period.

[Maya Iskandarani, Equity Research Associate - Biotechnology at H.C. Wainwright & Co., LLC]

All right, thank you. And can you confirm that timelines are similar if not the same as before the addition of the JOPS product for compression to the protocol?

[Barry Wolfenson, EVP - Strategy & Corporate Development at MediWound]

Yes, it doesn't change the timelines at all. The follow-up period is a three month period. That's always been part of the study.

[Maya Iskandarani, Equity Research Associate - Biotechnology at H.C. Wainwright & Co., LLC]

Okay, thank you very much.

[Ofer Gonen, CEO at MediWound]

Thank you.

[Operator]

Thank you. Next question comes from the line of Michael Okudovich with Maxim Group. Please go ahead.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

Hey, guys. Thank you so much for taking my questions today. Congrats on all the great progress.

[Ofer Gonen, CEO at MediWound]

Thank you for joining us.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

I guess just to start out, on the value study, has the patient recruitment and enrollment process matched your expectations? I know you haven't given specific numbers, but I guess just is the trend going in a favorable way? Is it exceeding expectations? Could you give a bit more color on that?

[Ofer Gonen, CEO at MediWound]

As you can as I said, one of the main focuses of MediWound is executing on this trial. As you know, we succeeded in fourteen out of 14 clinical trials in the past. Our main objective is to succeed in this most important trial. So the enrollment is progressing well. In The United States, most sites, almost all of them, are already active and recruiting patients.

[Ofer Gonen, CEO at MediWound]

In Europe, the activation is a little bit slower due to regulatory timelines. You know, while IND review in The United States typically takes thirty days, under the CTIS system in Europe, the process can extend up to one hundred and six days because of multi country coordination, etcetera. But all these steps are complete and the European sites are being activated. It's too early to say if we are going to meet the expectation, but currently, so far so good. We feel that the trial itself generated a lot of interest both in The United States and in Europe.

[Ofer Gonen, CEO at MediWound]

There are many patients, as you can imagine, we are focusing on picking the right ones in order for this trial to be a success.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

Thank you for the additional color there. Now also, you're now collaborating with basically all of the major wound care companies. So my question is, will having six different products across both of the pivotal studies, is this going to basically demonstrate to physicians that EscharEx can be used universally regardless of whatever preferred supportive products they have?

[Ofer Gonen, CEO at MediWound]

Barry, do you want to address this question?

[Barry Wolfenson, EVP - Strategy & Corporate Development at MediWound]

Sure, yeah. Hi Mike, good question. As we did in the for the CTP or skin substitutes where for the VLU study we're using EpiFix and for the DSU it's Kerasis Coloplast. This is why for the moist wound, the advanced wound dressings we're using Mundeleca in the VLU and now we're going with ConvaTec for the DFU is to hit that exact goal that you stated, to just to indicate that escharEx does not need to be used alongside of any particular PTT or wound dressing or kind of compression therapy, but it could be used with any product that would be considered standard of care.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

Yep, thank you. Great to hear. And then just one last one for me before I hop into the queue. What areas currently are particularly underserved for NexoBrid? Are there any particular regions where you expect the excess demand will fill as your new manufacturing comes online?

[Ofer Gonen, CEO at MediWound]

It's as if you participated in our internal meetings because we are discussing it internally quite thoroughly. The demand is quite substantial these days across all the regions, but the reason can be that all of them know that we are limited. So every territory wants to make sure that they have enough NexoBrid, so maybe they a little bit inflate the demand. As far as we are concerned, once we have the if you look at our guidance, we feel strongly that we can meet the guidance for the upcoming years. And if we will have a positive surprise in a certain territory, that will just serve us.

[Ofer Gonen, CEO at MediWound]

Other than that, we just know that we have additional demand. We are not spending energies at all on marketing. And I believe that next year, after the facility is completed and approved by FDA and EMA, I think we will have better color on that.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

All right. Thank you very much. And once again, congrats on all the great progress you're making.

[Ofer Gonen, CEO at MediWound]

Thank you.

[Operator]

Thank you. Next question comes from the line of Chase Nicheboker with Craig Hallum. Please go ahead.

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

Good morning. Thanks for taking the questions. Maybe just to start on the DFU side of things. Could you give us an update on kind of the timelines as far as when and how you'll get that relevant feedback that you need from FDA to kind of finalize design? And then just can you give us an update on kind of how you're thinking about the timelines there? Thanks.

[Ofer Gonen, CEO at MediWound]

Hey, Chase, great to have you with us again today. As for the DFU, we guided that in the second half of the year, which means, as we speak, we are approaching the FDA in order to get feedback on the protocol for the next study. These processes typically take around ninety days. I think we will be then ready to get ready for the trial, but according to our guidance, we'll start in the second half of next year, and we are on track with that as well.

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

Got it. And then just a little bit more granular maybe on the VLU side. Can you give us an update on kind of the 40 centers, how many are active Sorry if I missed it. And then, you know, there's at some wound care centers, there's some competition for patients for some of these

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

SkinSub trials. Can you speak to if you're seeing any sort of competition for patients from some of those trials, just kind of general thoughts on enrollment is kind of what I'm looking for, Ofer.

[Ofer Gonen, CEO at MediWound]

Again, this is a great question that keeps us awake at night. There are around 50% of the centers. We aim to open around 40 centers. We are not giving granular numbers, but we are getting to that target. We are very close to that, to open 40 centers, 50% of them in The United States.

[Ofer Gonen, CEO at MediWound]

The vast majority of the sites in The United States, maybe one or two are not open, all of them are open, activated, and recruiting patients. So in The United States, we are where we expect it to be. As for Europe, it's too early to say. What we said that by the end of the third quarter, we think that the majority of the sites will be open there, and I think that we will meet this guidance as well. I strongly believe that we will meet this guidance as well.

[Ofer Gonen, CEO at MediWound]

So in Europe so in the Phase III trial, according to our plans, we are in a good shape. As for competition, the competition of additional trials, of course, is irrelevant for Europe, because the vast majority of the trials of CTPs are now in The United States. When we chose the trial, we did a process of validating sites that we feel that are the best for our needs. We made sure that the trials are being done in places without competition. Of course, things varies and changes from time to time.

[Ofer Gonen, CEO at MediWound]

Currently, we don't see a big impact from CTPs. I'm not sure that a CTP trial can compete with a biological trial. Each patient in our trial cost around $100,000 I'm not sure that these are the numbers that CTP trials that are much simpler. I'm not sure that this is the number that they are paying.

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

Understood. And then, just last for me. You know, I had gotten your thoughts on we had gotten your thoughts on this previously. But, you know, the CTP SkinSub reimbursement kind of changes that are now kind of being proposed are a little bit different than before with that with the price cap that's being proposed. As we move into the final rule in November, we'll see how that shapes up.

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

But can you kind of give us any thoughts as far as how you think that impacts the industry and how it might relate to future utilization of SCRX?

[Ofer Gonen, CEO at MediWound]

Yeah, sure. This is also something that we are into many details about it. Barry, do you want to step in?

[Barry Wolfenson, EVP - Strategy & Corporate Development at MediWound]

Sure, of course. Hey, Chase. As far as the question on how it's going to shape the industry, my frank belief is it will help to clean up the industry. You know, around these skin substitutes there's been issues over the years and a couple of these changes will really help to clean things up. One of them being that only those products that have demonstrated good clinical evidence will be eligible for Medicare reimbursement.

[Barry Wolfenson, EVP - Strategy & Corporate Development at MediWound]

And within that changed local coverage determination document there's also stipulation that the wounds need to be properly prepared. So they need to be fully debrided and ready for application of a skin substitute prior to being eligible for reimbursement. And of course, especially given the publication that we've just announced today on the importance of wound bed preparation and how SRX impacts that, this is a huge win for us. This is what SRX does well and it will be well suited as a tool for anyone on that side of the business that's looking to apply a CTP onto a patient. And then the second part of it is a cleanup of the pricing loophole, which will bring everything back down to a similar level.

[Barry Wolfenson, EVP - Strategy & Corporate Development at MediWound]

And it will allow really the better products to flourish. And for physicians to look for ways to more quickly get to use these CTPs. And we think again that that's going to be where escharEx provides impact because of its quick time to complete debridement and wound bed preparation.

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

Great. Thanks, everyone.

[Ofer Gonen, CEO at MediWound]

Thank you, Trey.

[Operator]

Thank you. Next question comes from the line of Scott Henry with AGB. Please go ahead.

[Scott Henry, MD & Senior Research Analyst at Alliance Global Partners]

Thank you and good morning or afternoon depending on your location. A couple questions. First, you did reiterate that the manufacturing expansion is on track, operational capacity by the end of the year 2025. Could you talk about when you would expect to file in the EU and in The U. S? I believe the EU is first. Thank you.

[Ofer Gonen, CEO at MediWound]

Hey, Scott. Yeah, demand for NexoBrid is rising with those new launches and governmental interest and all the expanded indication that we are working on. So capacity is one of the biggest issues that we are addressing, because it is critical to support the global growth. The commissioning process, all the validations and everything that is required in order to be done is progressing well. What we guided that by the end of the year, everything will be completed, and we will start submission to the regulatory authorities.

[Ofer Gonen, CEO at MediWound]

Stability testings in the for Europe is three months, and in The United States, it's six months. So our estimation that in the 2026, we will get approval from EMA, and in the 2026, we will get approval from the FDA. The guidance of the revenue that we are presenting reflects those estimates.

[Scott Henry, MD & Senior Research Analyst at Alliance Global Partners]

Okay, great. Thank you for that color. And then with regard to NexoBrid, given the capacity you have currently, we did see some growth from first quarter to second quarter, but the level is somewhat limited for the past kind of five quarters. Do you think will there be any room for expansion in the 2025? Or are you just limited by the ability to make the product?

[Ofer Gonen, CEO at MediWound]

So again, we have a guidance of $24,000,000 revenue in 2025. We are able to meet this guidance. The surplus of the revenue will not come from additional NexoBrid. NexoBrid, we have zero inventory. Everything which is manufactured immediately is being sold.

[Ofer Gonen, CEO at MediWound]

The additional the ramp up in the revenue in the second half of the year is from development services and not from NexoBrid. The ramp up with NexoBrid will be available only once we will get the first approval, EMA approval, for the new facility.

[Scott Henry, MD & Senior Research Analyst at Alliance Global Partners]

Okay. Great. And I know you've talked about, BARDA funding already in the call, and it seems like that's very much on track. But three months ago, six months ago, there was some concern about BARDA funding in general given the political environment in The U. S.

[Scott Henry, MD & Senior Research Analyst at Alliance Global Partners]

Is that environment currently? Are you back to kind of normal operations? Has it eased? Or is there any overhang left from that political environment?

[Ofer Gonen, CEO at MediWound]

So this is a great question. In the previous quarter, we said that we had some delays in receiving revenue from both BARDA and DoD. And this quarter, you see the opposite. You see that debriding burns or treating burns people or burns soldier became kind of a priority. BARDA submitted an RFP.

[Ofer Gonen, CEO at MediWound]

BARDA decided to support building a manufacturing facility in The United States. The Department of Defense increased the award, the non dilutive funding that they are granting us for development of a room temperature stable formulation to be used in the battlefield. So as far as we see, these projects are considered a priority around the Department of Defense and the Ministry of Health of the United States, and we are, of course, satisfied with that.

[Scott Henry, MD & Senior Research Analyst at Alliance Global Partners]

Okay. Great. And perhaps a final question for Hani. Expenses in the quarter, I believe, roughly $7,000,000 operating expenses. Would you expect that to increase in the second half?

[Scott Henry, MD & Senior Research Analyst at Alliance Global Partners]

Or is that kind of a high watermark? It was a little higher than the first quarter. Just trying to get a sense of the trends.

[Hani Luxenburg, CFO at MediWound]

Hi, Very good question. So in respect to our operating expenses, I will expect it to increase a little bit in the second half. As Ofer mentioned before, in The United States, most of the sites already recruiting patients, but in Europe, there was a slight delay because of the regulatory process, and those steps are now completed in Europe and European sites are being activated. This will result in higher R and D expenses in the 2026. Hope I answered your question.

[Scott Henry, MD & Senior Research Analyst at Alliance Global Partners]

Sid, that was great. Thank you. And thank you for answering the questions.

[Operator]

Thank you. Next question comes from the line of Maya Escandarani with HCU Enright. Please go ahead.

[Maya Iskandarani, Equity Research Associate - Biotechnology at H.C. Wainwright & Co., LLC]

Thank you for taking my additional question. My question is actually also related to FDA turnover and the possibility of delays. So for the new NexoBrid facility, are inspection timelines on track? And otherwise, do you expect any changes to that timeline? Thank you.

[Ofer Gonen, CEO at MediWound]

Hi, Maja. Again, this question is we are participating in all kinds of seminars and trying to understand exactly how FDA what the plans are for inspecting facilities that not in The United States. As far as we understand, inspections that are not expected now, let's say they're expected in one or two quarters from now, no one sees any problem with those. And since the FDA inspection is only expected in the second half or in the end of the 2026, we don't see any issue with that. Having said that, if you look at the guidance of our revenue, it is mainly determined by the approval of EMA, and there are no issues with approving our facility by the EMA because the inspectors are Israelis.

[Ofer Gonen, CEO at MediWound]

So our estimation is that early or by half, by mid-twenty twenty six, the new facility will be able to manufacture substantial amounts and to send it to territories that are substantial, like Europe and other countries that are linked to the EMA.

[Maya Iskandarani, Equity Research Associate - Biotechnology at H.C. Wainwright & Co., LLC]

Okay. And a quick follow-up question. Are the BARDA, RFP and new DoD funding both able to be used for the development of the room temperature stable formulation?

[Ofer Gonen, CEO at MediWound]

You are on spot. Importantly, BARDA has also expressed an interest in the program of the room temperature stable formulation that initially was funded by the DoD. In the recent RFP that BARDA just published, you can see that room temperature stable formulation for nonsurgical debridement is specifically highlighted as one of the area of focus. As you can imagine, NexoBrid that is stable in room temperature can be used not only for soldiers not only for military uses, also a lot of civilian scenarios are relevant. So yes, both agencies are very interested in this program.

[Maya Iskandarani, Equity Research Associate - Biotechnology at H.C. Wainwright & Co., LLC]

Okay, that does it for me. Thank you.

[Ofer Gonen, CEO at MediWound]

Thank you, Maya.

[Operator]

Thank you. This concludes our question and answer session. I would now like to turn the conference back over to Ofer Konin for closing remarks.

[Ofer Gonen, CEO at MediWound]

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. You for attending today's presentation. You may now disconnect.

Participants

Executives

• Ofer Gonen, CEO
• Hani Luxenburg, CFO
• Barry Wolfenson, EVP - Strategy & Corporate Development

Analysts

• Dan Ferry, Managing Director at LifeSci Advisors, LLC
• Joshua Jennings, Managing Director at TD Cowen
• Maya Iskandarani, Equity Research Associate - Biotechnology at H.C. Wainwright & Co., LLC
• Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group
• Chase Knickerbocker, Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC
• Scott Henry, MD & Senior Research Analyst at Alliance Global Partners