MediWound Ltd. Price & Performance (MDWD)

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 Gunn, Chief Executive Officer of MediWound Hany Luxemburg 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 and A. Now I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound.

Ofer? Thank you, Dan, and good morning, everyone. Twenty twenty four was a pivotal year for MediWound.

Marked by marked by strong execution significant progress in clinical development, commercial expansion, and strategic partnerships. These achievements have strengthened our position enabling us to drive continued growth and innovation in 2025 and beyond. I'll begin with EscharEx, our next generation asthmatic debridement therapy for chronic wounds. In early twenty twenty four, we reported compelling results from our head to head analysis against Santil. Currently, the only FDA approved in somatic debridement product in The United States, generating approximately $370,000,000 annually. The data demonstrated EscharEx's superiority over Santir, across key clinical endpoints, including higher incidence of complete debridement, faster time to complete debridement, more rapid and effective wound bed preparation, and faster time to wound closure. [indiscernible] diverse care settings recognize these superior clinical benefits the substantial value they provide. In fact, recently conducted market research estimates EscharEx peak sales potential at approximately $725,000,000 its primary indications, venous leg ulcers and diabetic foot ulcers. These clinical benefits also make EscharEx well positioned for upcoming changes in wound care reimbursement. Starting next month, Medicare's new LCD policy will require full wound debridement and granulation tissue formation before before covering cellular and tissue based products. This shift strengthens EscharEx's opportunity as a major commercial opportunity for our company.

EscharEx now is in phase three, We recently launched the value global phase three trial to evaluate EscharEx for venous leg ulcers, enrolling two sixteen patients across 40 sites in The United States and Europe. The co primary endpoints of the trial are the incidence of complete bribe and the incidence of wound closure. This program is strategically de risked, building on the strong results of our Phase II studies with key modifications to maximize the likelihood of success. Modification that a larger patient sample size, to strengthen statistical power, interim analysis at 65% enrolment, allowing for adaptive adjustment, and standardized treatment protocols minimize variability and ensure consistency. It is also important to note that EscharEx shares the same active pharmaceutical ingredient as NexoBrid, which is FDA approved nearly identical indication, eschar removal. The interim assessment, significant milestone, is anticipated in mid-twenty twenty six, with full trial completion expected by year end twenty twenty six.

To further strengthen our BLA submission and enhance commercial readiness, we are planning a 45 patient randomized, prospective prospective Phase II head to head comparison of EscharEx versus collagenase scheduled to begin in 2025. This study will include both Santyl and the European collagenase product [indiscernible] generating critical comparative data that will be instrumental in support of our market access and pricing strategies. The VLU program is supported by research collaborations with leading wound care companies, Sorventum, Molnike, and Nimetics. These partners will provide advanced wound products for our trials, ensuring optimized patient outcomes and standardized wound management across all sites.

Additionally, earlier in 2024, we secured €16,500,000 in funding from the European Innovation Cancer to accelerate the development of EscharEx for diabetic foot ulcers. The Phase IIIII DFU clinical trial is planned for 2026 and we are pleased to announce a new strategic research collaboration agreement with Keresys, a subsidiary of Coloplast, to support this effort. [indiscernible] Is a global leader in wound care solutions, will be supplying its fish skin graft for active closure in this trial. Additionally, we anticipate securing another collaboration with a major industry leader, to supply their market leading advanced wound care dressings. With these partnerships, MediWound will be working alongside all the relevant key players in advanced wound care, reinforcing our strong industry positioning. Now let's move to NexoBrid, our innovating enzymatic therapy for severe burns. Before we discuss our progress with NexoBrid, I want to take a moment to highlight its critical real world impact. This past weekend, a devastated nightclub fire in North Macedonia claimed fifty nine lives and injured at least one hundred and fifty five people. A medical delegation from Israel equipped with NexoBrid immediately flew in to provide support and treatment. We are grateful that NexoBrid could play such a vital role in this strategy.

With that said, in 2024, we achieved significant progress in expanding NexoBrid's commercial reach, generating annual revenue of $20,200,000 driven by robust global demand. Moving forward, we anticipate continued strong growth, with projected revenue of $24,000,000 in 2025, capped only by our manufacturing capabilities. This growth will be driven by expanding sales in key markets, Europe, where NexoBrid is now available in more than 90 burn centers, Japan, where our partner, Kaken Pharmaceutical, has achieved a remarkable adoption with 400 plus medical facilities using NexoBrid, and The United States, where Vericel's strong commercialization efforts yielded a 42% increase in hospital orders in q four twenty twenty four. NexoBrid market's potential was further expanded with FDA approval for pediatric patients newborn to 18 years old. The pivotal Phase III pediatric study data supporting the approval were recently published in Burns, a peer reviewed journal the International Society for Burn Injuries. Another potential indication expansion emerged during the Israeli Hamas war, where dozens of patients with blast injuries were treated with NexoBrid. The outcomes were remarkable, and the data from these cases will be presented at the upcoming American Burn Association conference. Additionally, we reported positive results from the expanded access protocol, NEXT, evaluated two thirty nine patients across 29 U. S. Burn centers.

The study confirmed NexoBrid's safety and efficacy in removal, as well as its significant reduction in the need for surgical procedures for burn patients. Operationally, we successfully completed the construction of our state of the art GMP manufacturing facility, which remains on track to reach full operational capacity by late twenty twenty five. Commercial availability will depend on regulatory approval from FDA EMA, which are expected in 2026. This facility will significantly expand our production capabilities allowing us to meet the growing demand the growing global demand and sustain long term revenue growth.

This year we also strengthened our balance sheet with a strategic $25,000,000 pipe financing round led by Molnicki. This reflects industry confidence in our strategy, provides additional resources to execute our clinical and commercial growth plans. With a robust cash runway of approximately $44,000,000 MediWound is well positioned to deliver on its critical clinical, operational and commercial objectives. Now I'd like to turn the call over to Hany review our financial performance in greater detail. Thank you, Ofer, and good morning, everyone. I'll now take you through our financial results for the first quarter and full year of 2024. Starting with the fourth quarter, we reported revenue of $5,800,000 compared to $5,300,000 in the same period last year. Gross profit came in at $900,000 gross margin of 15.5% up from 700,000.0 and a 13.5% margin in Q4 twenty twenty three. R and D expenses were 3,000,000 compared to $1,800,000 in the prior year quarter primarily due to costs related to the EscharEx value face III trial. SG and A expenses [indiscernible] $4,000,000 compared to $2,800,000 in Q4 twenty twenty three mainly reflecting higher share based compensation expenses. This resulted in an operating loss of 6,100,000.0 compared to $3,900,000 last year.

Net loss for the quarter was 3,900,000.0 or $0.36 per share compared to $1,700,000 or $0.19 per share in Q4 twenty twenty three. On a non GAAP basis, adjusted EBITDA loss was 4,900,000.0 compared to $3,200,000 in the same period last year. Now moving to full year, we reported total revenue of 20,200,000.0 compared to $18,700,000 in 2023. The increase was primarily driven by higher revenue for Vericel, and new contract with the U. S. Department of Defense. Gross profit for the year was 2,600,000.0 with a gross margin of 13% compared to 3,600,000.0 and a 19.1% margin in the prior year. The decline was mainly to changes in revenue mix and higher fixed costs associated with scaling our production. R and D expenses came in at 8,900,000.0 compared to $7,500,000 in 2023 primarily due to related to EscharEx value Phase III trial. SG and A expenses were 13,100,000.0 compared to $11,600,000 in 2023, mainly reflecting higher share based compensation costs. Our operating loss for the year was 19,400,000.0 compared to 15,300,000.0 in 2023. Net loss for the year was 30,200,000.0 or $3.3 per share compared to 6,700,000.0 or $0.75 per share in the prior year. The $23,500,000 increase was primarily due to financial expenses mainly from the revaluation of warrants following a 75% increase in our share price in 2024.

Non GAAP adjusted EBITDA loss for the year was $40,800,000 compared to 12,300,000.0 in 2023. Turning to balance sheet we ended the year with $43,600,000 in cash cash equivalent and deposit compared to 42,100,000.0 at the end of twenty twenty three. During the year, successfully raised $25,000,000 through PIPE offering, received $1,200,000 from the exercise of Series A warrant, and secured $1,200,000 grant from the European Commission. We also fully settled our liability with Teva. In total, we used $22,900,000 to fund operation including $6,800,000 allocated to capital expenditure, primarily for scale of our manufacturing facility. That concludes my financial review. Offer. Back to you.

Thank you, Jaime. So in summary, 2024 was a transformative year for MediWound. Defined by significant clinical, commercial, and strategic achievements. Our strong execution expanding pipeline, and key partnerships position us for sustained growth and long term value creation. As we continue to advance our programs, expand market adoption, and drive innovation, our focus remains on delivering meaningful improvements in patient care. We look forward to providing further updates in our progress in the coming quarters. And with that, I will now turn the call back to the operator to the line for questions. Operator?

Thank you.

Yes, sir. We will now begin the question and answer session. If your question has already been addressed, you'd like to remove yourself from queue. Please press then 2. Today's first question comes from Josh Jennings at Cowen. Please go ahead. Hi. Good morning.

Good afternoon. Thanks for taking the questions and congratulations on the initiation of the value study.

Appreciate all the review of the trial design and the path forward. One follow-up, you have some powerful wound care collaborators in this study, [indiscernible] [indiscernible] you know, what is, outside of supplying their wound care products, for the study, what else are they doing in terms of enhancing study execution? Just wanted to get that under our belt. So hi, Josh, and thank you for the question. Barry, do you want to address it?

Yes. Thanks, Josh, for the question.

Generally speaking, having standardized products across these three key categories, the moist wound dressings, the compression bandaging and the tissue substitute.

Will help just to make sure that all variability is minimized throughout the study, which of course will optimize the outcomes. As far as the companies themselves are concerned, aside from products that they'll be supplying, they'll also be supplying training.

So in fact this weekend in Philadelphia we have our investigators meeting and there'll be training of all the sites Those companies will be involved and and on an ongoing basis if there are any questions related specifically to their products, they'll provide that education and training.

Excellent, thanks for that. And I wanted to ask about the DFU study expected beginning 2026. Maybe funding is in place is to two part question. I mean, one should we expect it to be a global trial with the EU funding similar to the VLU study, the value study? And then to maybe just outline what's required just a similar pathway that you took for VLU in terms of getting trial design approved by the FDA and EMA. Love to just hear you walk us through that again, sorry to make you review it. So the phase three study with DFU patients will be as close as we can to this Phase III study of the VLU patients. The only difference is we have less data that we have for VLU patients, so in order for the agencies to agree to that structure of the study, need to their sign of Our our plan is to approach both FDA and EMA in the half of this year with a protocol that is based on the data that we have to date. We have few dozens of patients that we treated with DFU patients, and they data looks basically similar to what we have with the video.

But we need to have it approved. This is why when we guide about the study, we say a phase twothree study, because maybe we need kind of an interim assessment and shift into a Phase a phase three down the road. Having said that, we need to get clearance from the agencies we can give a lot of details. Our thoughts about how the study will look like is currently posted on our website, and it looks quite similar to the VFU trial. With this trial we will also have strategic collaborations same as we have with the VLU trial, but it will be with different partners.

Excellent. And just one last one on NexoBrid. You guys have made great progress in terms of building the state of the RTMP manufacturing facility in place, and ramping up capacity this year. Understand that regulatory approvals are necessary for the product to be commercially available. Which is when's the earliest that regulators can get in to, I guess, do the inspection and move forward with clearance. I know you don't have any control over over the timing, but when's the earliest that they could start that process? And it sounds like you're expecting approvals in '26.

So currently, I was guidance for the revenue are reflecting the fact that we will get in the beginning of twenty twenty six approval in Europe And by mid twenty twenty six, we'll get FDA approval. The thing that we need to have in place in order for those approvals to take place is that we need to make sure that we are able to manufacture product with the same quality and the same characteristic of the current manufacturing facility that we have, which is quite smaller. After we finish proving that we can do the same, we need to manufacture a few batches of both NexoBrid for The United States and for Europe, Europe demands three months of stability that, they come they can come for an inspection. This is why we expect the European approval to be earlier. And the US FDA the guide guidelines is that we need to wait six months of stability. So these are the timelines, and this is why we guided the beginning and in the middle of 2026 both approvals.

Thanks, Sophie. Thanks, Barry.

Appreciate it.

Thank you.

And our next question today comes from Francois Breezebois with Oppenheimer. Please go ahead.

Hi, thanks for the questions and congrats on the progress this year.

In 2024. I was just wondering if you can touch base, you started your call talking about the Medicare update. You just remind us when that came in place and how just a little more color on how do you think that is a positive for MediWound? And then the second question is more on the interim analysis. Just a reminder, I think you mentioned it on the timing of that for the trial the phase three and are the different kinds of outcomes that can come out of this interim analysis? Thank you.

Okay, thank you for the question. Barry, can you step in to address the first question and I will answer the interim assessment one?

Sure. Of course. So with regard to the Medicare question, recently as you're likely aware, the seven local MACs, the Medicare administrator contractors, posted final changes to what's called an LCD, a local coverage determination. [indiscernible] related to the usage of cellular and or tissue based products. [indiscernible] This category has exploded in the last several years, to as high as 3,000,000,000 in The US. And while several dramatic changes were written into the draft policy, as it turns out the final policy ended up not really too different than the current one. This new policy becomes active in less than a month on 04/13/2025. One key change is the slight limitation on the number of applications tissue. That could be put in place on a patient during one complete episode. That number has gone down from 10 previously to four. But it does have the ability to do an additional four if the wound situation warrants. Additional applications. And for these additional four, the sites must complete some additional [indiscernible] But that extra work is not deemed to be too time consuming to keep them from doing so. That's the bigger change that the industry industry will focus on.

From a MediWound perspective and how it relates to escharEx, another meaningful change from this new LCD is the increased attention to documentation required showing that the wound is completely debrided and in granulation tissue, prior to application of any tissue substitute to the wound. And given that this is what EscharEx does so well, it debrides and it gets wound bed the wounds prepared. This will position our drug as the optimal product of choice when surgery or sharp debridement is not deemed to be the best option.

Okay. Barry, I have nothing to add to that. Thank you for answering. As for the interim assessment, assessment, as I said in my prepared this program is strategically derisked. MediWound succeeded in 14 out of 14 clinical studies, and we have no plans to fail in the most significant that we are conducting. So we plan an interim assessment after sixty five percent of the patient in the study, which is one hundred and forty patients, are treated, and there are two outcomes to this assessment. One, ninety percent there is a ninety percent probability of success. The ninety percent power for success is maintained. And in this case, we are stopping the enrollment of the study, By then, more than two hundred patients will be already included in the study. And then we just are waiting for the follow-up and the study is done. If we see that the likelihood of likelihood of success is less than ninety percent, let's say it's seventy seven percent, we have some flexibility in the protocol to include additional few dozens of patients, in order to maintain the ninety percent probability of success. If everything goes as we planned, the interim assessment should be by mid-twenty twenty six, and the study completion assuming the ninety percent probability of success is maintained, the study completion is by the end of twenty twenty six.

I hope I answered the question.

Yep, thank you.

And our next question today comes from RK from H. C. Wainwright. Please go ahead.

Thank you. Good afternoon, Ofer and Hany, and good morning, Barry. A couple of questions. Barry, thanks for explaining the LCD the new LCDs, you know, that was that's gonna become official, you know, in a month. So based on what you were saying regarding the the the granulation of the tissue, is there a way where you at least if you can compare for us how santinel performs versus what we should expect from EscharEx. And and you know, based on that, does EscharEx has has potential to be better than than what Santanol does right now?

So Barry, do you want to address it?

Sure.

Well, a couple of things. Firstly, and thank you, RK.

For the question.

As you know we announced the results from this head to head Phase two study earlier this year And EscharEx was shown above Santal in all the endpoints, whether that was time to complete debridement, incidents of complete debridement, and also time to wound closure. With regard to the so so right there off the bat if you're a treating physician and you have a wound that comes in, and you want to get towards a CTP for active closure, you're going to know that the data suggests that escharEx can get to that CTP within only a couple of weeks.

That the average is going to be five to six applications within a couple of weeks, and published data, even outside of, for Santo, even outside of our Phase two analysis suggests that it's more along the lines of six to eight, if not even more weeks. So there's going to be an incentive to use escharEx because it will get to that CTP application much much more quickly than would SANTLE.

Thank you for that. And then Ofer, a quick question on the VLU the ongoing VLU study. Is there any possibility for this study to enroll quicker than expected, so that know, we can expect data earlier. Whether it's the interim or or the final complete dataset later next year.

Yeah, so hi, Arke, and thank you for this question. A great question because I was asked about it again and again by my Board yesterday. I wouldn't expect a quicker enrollment That many patients, we are in the largest centers in The United States and Europe, There are a lot of patients that are available but we are making sure that we are recruiting the right patients. I want patients with real chronic wounds, I I don't want patients with a wound which is not that severe, and even a placebo will do something. So we're spending a lot of time and a lot of effort in screening and making sure that no patient is getting into the study unless he has a real chronic wound a real heart rate wound because our intention is that placebo will do nothing to it. I don't mind waiting another month, another two months are not incentivizing centers to recruit as many patients as they can, as quickly as they can. On the contrary, I'm just making sure. It's a very lucrative study, Everyone wants to get to be treated with the ancillaries that we are getting the most expensive dressings, the most effective pressure garments, We know that there is a lot of demand to participate in this trial, Our motivation is to make sure that it is done adequately and I would not expect quicker [indiscernible] Okay.

Thanks for that. And then on the collaboration with BARDA, in terms of identifying a US facility and trying to plan and design a facility in The United States What is the status there? And also, can you give us any color as to how you're going to manage these big projects. Like, you just got done with the Israeli facility, and you know, what's the timeline, you know, if you so decide and identify a specific site in The United States And how does it play into the expansion of NexoBrid? From What You're Yet To Accomplish That's Already Been Signed Up For.

So The Facility In Israel that is going to be in full capacity scale by the end of this year and getting the approval by mid next year, we will have there the capacity to support the foreseeable market of NexoBrid both in The United States and globally. Having said that, the U. S. Government recognized the need to having to having a backup facility in The United States. So we are now in the pool. So we got some funding to identify a location an ID location for such a facility. Are planning such a facility. We are we are having additional indications such as the temperature stable formulation and additional indications indications that we are working on that this facility will need to support. So we have the funding for that.

Hopefully by the end of this year. We will know exactly what is required in order to finalize building such a facility, I would expect a three year product. It will not have any impact on our revenue guidance because we are speaking now on 2027, 2028. But we will have a lot of additional capacity either to manufacture more EscharEx or to manufacture the military use indication, etcetera. So it's a project which is very important for us. But it won't have any impact on the next four years other than getting funding from the US government.

Perfect.

Thank you very much. Thanks for taking my questions.

Thanks. Thanks, Ake.

And our next question today comes from Chase Snickerbocker with Craig Hallum.

Please go ahead. Good morning. Thanks for taking my questions.

Just a couple on the VLU study.

Around enrollment. So can you just kind of queue us in on what you're hearing from prospective centers as far as what they think enrollment rates that are feasible are. And then how are the early site activation activities going Everything is planned so far? And then along those lines and with the LCD, there's a number of skin subtrials going on as a result of the clinical evidence requirements in that LCD we were referencing. Are you watching out for any competition for patients? Or kind of what are you hearing from these centers? Sorry for the multi parter. Thanks.

So, hi, Jason. I hope I remember all the part of the question. Let's start with the end because this is how my memory works. When we did the feasibility study, feasibility testing about which sites to pick, we chose sites that do not have competing trials. Having said that, we might have one trial or two competing in specific sites, but none of them can compete financially in our trial. We are much complicated trial. We are paying much more money for each patient per center, around $100,000 per patient, which is at least three or four times more than they are getting from simpler CTP trials, so we do not identify it as an issue. This is the last part of your question. As for the rates, we are aiming for the same rates that we had in the previous Phase two chronic study, which is half a patient [indiscernible] per month. Very feasible. It is also based on the experience of the CRO that we are working on in this phase three study. And it looks something that all our calculations are based on these numbers. It can be a little bit quicker, but as I said, as I answered to, I think, RK, I don't we are not pushing to are not we are we are we are focusing on the quality of the trial and not in trying to recruit as many patients as possible quicker, because the patients are there.

Did I miss any part of the of the patient? Chase?

Yeah. Yeah. And then just, kind of act on on the site activation side, that was all very helpful. And just on the site activation side, has everything kind of happened to plan? Anything that's going better or anything that's taken a little bit longer? I know it's early days.

Currently, we were well prepared prepared to start the study. We have the agreements in place, and this the sites are very enthusiastic and we don't see any delays. On the contrary, we again, we started we are we are we just started in The United States, so at least something like 50% of the sites will open only in the next couple of months. We are in a very good place. And in The United States, there is a lot of enthusiasm around this specific trial.

Good, and then just maybe one for Hani. If we think about R and D spend this year as the VLU trial ramps, up, is that kind of per patient as they're enrolled the right kind of way for us to think about it and model R and D? Or are there other kind of start expenses we should be thinking about? Maybe just kind of any way you can help us think about R and D spend in 2025? Thank you.

Yes. I think that in 2025, our R and D expenses will increase compared to 2024, Of course, it derives from, as Ofos said, per patient, the cost will be around 100 k US dollar. So as we aiming to enroll around the 100 patients this year. You can do the calculation and the result is that we will the R and D cost will increase substantially compared to 2024.

Very helpful. Thanks for the question.

Thank you. And our next question comes from Michael Okunowicz with Maxim Group. Please go ahead.

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

I guess first off I'd just like to ask a little bit about on the DFU study, could you talk about the for partnering with TerrAsys and and does this replace the MEMEDEX grafts or is it a different type of graft?

So the rationale is that we want to work with the best products, and we don't want to be associated with a specific advanced wound care company. So if you look at [indiscernible] the best data as far as we know in venous leg ulcers are MiMedix's, and this is why we signed with them. The best result that we see in diabetic foot ulcers are of keratosis coloplast. This is why we picked them. As you can imagine, and based on the environment and the CPP and the LC and the reimbursement all of them are interested to participating in such trial to generate more data and to be used by as many sites as possible. We have the ability to choose, and we are happy with those specific two partners that we picked.

Okay. And then when we look here 2025 revenue guidance, could you help us understand where that $4,000,000 in incremental growth comes from? If we are expecting the EMA approval on the facility to come in early twenty six?

Yeah, so as I'm saying, we do not expect to sell more NexoBrid units not substantial more NexoBrid units in 2025, but a couple of two or three weeks more that we can manufacture due to all kinds of activation effort that we had last year. So we have a few more weeks of manufacturing, and also we increased the price a little bit where we could, and we are shifting territories There are more profitable territories. So the numbers according to the current plan, the math shows that the revenue will increase quite substantially. But again, it is still based on the same capacity maybe another two or three weeks more and higher prices.

Okay. Thank you very much for the additional color.

Thank you.

Thank you. This concludes our question and answer session. I'd like to turn the conference back over to management for closing remarks.

So thank you, everyone, for joining us today. We enjoyed it. We look forward to continuing our dialogue and updating you on our progress during the next quarterly call. Bye bye.

Thank you. This concludes today's conference call. We thank you all for your participation, and you may now disconnect your lines. Have a wonderful day.

Thank you.