Good afternoon. I'm Josh Jennings from the TD Cowen Medical Devices Research Team. We are kicking off the afternoon track of the first day of the 46th Annual TD Cowen Health Care Conference. We're excited to have Barry Wolfenson, Executive Vice President, Strategy and Corporate Development of MediWound. I was gonna give a presentation. If there's time, we'll take a couple questions after. MediWound's got an exciting story. It's got NexoBrid that's commercialized and a partnership with Vericel, and they have a game-changing wound care product in clinical development, well into the clinical development program, EscharEx. We're gonna learn some updates today. Barry, thanks so much. I'll hand it over to you.
Thank you, Josh. I appreciate that. Small market, about $300 million TAM for severe burns in the United States that is sold by Vericel, as you mentioned, and EscharEx, which is our drug under development for chronic wounds, much larger market. We'll talk about it in a minute. We punch over our weight class with regard to the size of our company and clinical development. We are exceptionally good when it comes to R&D. We have 14 out of 14 successful clinical studies on our way, hopefully, to our 15th. Solid balance sheet of $54 million in cash. Our products, both NexoBrid and EscharEx in development, are surrounded by collaborators, good, strong global companies that validate the technology.
We manufacture everything in Israel with a plant that is set to expand to allow for six times capacity for NexoBrid. Again, we'll talk about that. Our API, NexoBrid, is one of four fully botanic drugs ever approved by the FDA. The API in NexoBrid is the same as the API in EscharEx. Basically, we take a suite of enzymes that are highly proteolytic from pineapples and create drugs out of them. We lyophilize them. They're made into a powder form. They're reconstituted into a gel at the time of application where they're highly efficacious.
If you were to look at the published literature, even outside of what MediWound has done on these enzymes, in particular bromelain, you'll see that it has potentially impact in cancer, anti-inflammatory diseases. Our focus thus far has been on in the derm space, so burns, wounds. We've done some work in basal cell carcinoma as well. We focus on the proteolytic activity, so anytime that there's tissue that needs to be selectively removed, our drugs could play a role. Again, these are the two commercial and near-term commercial assets that we have. NexoBrid, $300 million TAM. This is for the eschar removal of severe burns, so patients who are hospitalized, and they have deep partial thickness to full thickness burns. EscharEx, same API. Think of it as, you know, half the concentration as NexoBrid.
It's a daily application drug, it's for chronic wounds. Much bigger market. Severe burns in the United States, around 40,000 per year. Chronic wounds that would be applicable to EscharEx are around 4 million. That's the difference in the markets. NexoBrid, still being further developed. Much of the funding that we received in the early days and throughout the duration of our company to support the development of NexoBrid has come from the United States Government, both the Department of Defense, now the Department of War, and BARDA. It's a cold chain product currently, their interest in NexoBrid are for mass casualty events. You know, if there were something that happened where 50 people had severe burns, it would overwhelm virtually any city's burn centers.
With NexoBrid, you can line patients up, in theory, in a parking lot and treat them. It's an amazing improvement over something that requires surgery. Given that it's cold chain, the government would like to see a room temperature- stable product that could be carried out in the field for the war fighters. What we've learned in the post October 7th Gaza conflict is that so many injuries now in war have to do with blast injuries, whether it's shrapnel, particles from buildings that get embedded into people's skin. Surgeons have been using NexoBrid to help remove those particles. We're also receiving grant funding to expand into those indications. On the EscharEx side, we do have this phase III in venous leg ulcers. We're going to start a phase II for diabetic foot ulcers.
Pressure ulcers are the third of the big three chronic wounds. We will do an investigator-led study, small study on pressure ulcers, also starting in this year. As you can see, for this year, we're very busy. The three milestones I would have you look at are the manufacturing capacity increase. We've been building a plant within our plant to do a 6X increase in capacity for NexoBrid. Plan is completed at this point, and now it's just down to the EMA and FDA doing inspections for approval. As soon as the EMA does their inspection mid-2026, that'll free up all of the additional capacity. Product for Europe and for Japan will flow out of that.
The current facility which handles everything will be for the U.S. We'll have more than enough, and ultimately, towards the end of the year, if not next year, the FDA will do their inspection. On the EscharEx side, we have this phase III for the VLU, and the interim assessment is planned for, if we hit our timelines, for the end of this year. Closely after that, we'll have the last patient going into the study. This will help to reduce any kind of outstanding clinical risk. The last patient out will be in 2027. Again, from a balance sheet perspective, we have $54 million in cash. We have a revenue-generating business in NexoBrid, albeit small, is profitable on its own.
With the scale-up, we'll also achieve much higher margins, potentially to get to 65%. A series of great analysts, of course, with Josh right there at the top of the list. This is, sure, this is, you know, just a quick sort of timeline with regard to things that are happening and what needs to go on in order to hit our revenue projections for these next several years. As you can see in 2026, this is opening up that capacity, so we could start selling NexoBrid in other parts of the world, potentially to other governments for military use and mass casualty event preparedness.
With EscharEx, if we hit our timelines and the last patient goes in at the end of this year, out in 2027, we could do a filing in 2027 and have an approval at the end of 2028. When you look at the revenue projections, this year it's $24 million-$26 million. One of the things that you'll see as you scan across the years is that light blue bar is the government funding. We feel that that will remain fairly consistent year-to-year, and where you'll start to see the growth is the in-market NexoBrid sales.
$24 million-$26 million for this year, $32 million-$35 million for next year, and then it changes to a darker blue because we're adding some amount of EscharEx contribution into 2028, assuming approval towards the back end of that year. With regard to EscharEx, again, we're focused on chronic ulcers. The first two indications are both the lower extremity ulcers, venous leg and diabetic foot ulcers. There are some similarities with them. Again, it's around $4 million of these per year. The thing that's notable and why we went for leg ulcers first is they're incredibly painful.
The standard of care for wound debridement is still a lot of things that are used, but the standard is still gonna be, you know, sharp debridement, and approaching someone with a leg ulcer with a sharp object is not recommended. A lot of room for the clinical benefit and the need of a much less painful solution that's quick and effective. We'll do venous leg ulcers first. We're in our phase three. DFU we'll start the phase two. This is just a quick snapshot of what the market looks like. Again, there's a lot of different things that can be used for debridement, but if you look on the right side of the slide, you'll see those dark black bars. That's surgery and sharp debridement.
It's around 55% when you look at both VLU and DFU, so it's still the overwhelming majority. 18% is the one enzymatic drug that's in the market. We'll talk about that in just a moment. All the rest makes up, you know, it's fractured into tiny little bits. Our belief is that based on the market research that we've done, is that a product like EscharEx that could debride wounds in four to five days, certainly within two weeks, can expand that 18% to around 30% and will control about 22.5% of that. We have three phase II studies with very consistent results on the debridement, which is the primary endpoint. 60%-63% of wounds within the first two weeks get completely debrided within our arm.
You'll see other things like, biofilm disruption, bacterial load. There are other benefits to our drug, but the things that we focus on are the debridement and the fact that it prepares the wound for healing. Post-debridement, very quickly the wounds tend to get to a state of complete granulation, which just means that the blood supply is strong enough in the wound bed to take a graft. This video. Let's see if we can get it going. Well, you can't hear the sound. I'm not entirely sure why. What you'll see is. Oh, there it is. Is that after nine days, debridement is complete with ours. 11 days, the wound is prepared. In the protocol, it forces the patient to then have an autograft or a CTP, an amniotic tissue applied.
63 days is how long it takes to get to debridement for the control arm. Sorry for what is happening on this screen. The bottom line result is that our study-- I have to sort of explain this 'cause it didn't show up on the screen for those here in the room. It's two weeks of debridement and then 10 weeks of wound healing. The second primary endpoint that we have is not wound closure, it's the facilitation of wound closure. After the wound is debrided and it gets to complete granulation tissue in the protocol, then the patient gets either an autograft or this tissue applied. For venous leg ulcers, the data suggests that those things take three-six weeks to get to closure.
If we've 63% that reach that within two weeks and the control arm only has 30, you could just do the math and see that there's just not gonna be enough time on the clock in order for the control arm to catch up. Those are the two primary endpoints, the complete debridement within two weeks and facilitation of wound closure. Sorry about this technical snafu there. Okay, getting back into it. This is the one product that's available. It's called SANTYL, sold by Smith & Nephew, a large orthopedics company with a large wound care division within it. It's been on the market for years, decades, since the 1960s. The need for large scale clinical studies. Sorry, we're having a little technical snafu here with, I guess, the projector.
The need for clinical studies was not the same as it is now. Even then... Thank you. Even then, SANTYL's own data shows... It lasted for a second. SANTYL's own data shows that complete debridement is reached with that drug anywhere from 4 to 8+ weeks. With our drug, it's all, you know, within two weeks, four-five days is the average. It's a meaningful difference. Even though the data for SANTYL is not terrifically strong, it does $370+ million a year, making it one of the largest single brands in all of wound care. It's still a venerable drug, and gives us a clear lane to commercialize and really compete.
In fact, if you were able to see the screen, what I'm showing you is in the one of our phase two studies it was three arms. Active versus control versus standard of care. In the standard of care arm, physicians were permitted to use whatever they wanted. Eight patients had SANTYL. This data is those eight patients versus the 45 that were in the active arm. I'll just read it to you. 63%, as you saw earlier, of the wounds in the EscharEx arm got to complete debridement and none of the SANTYL patients within those two weeks got to complete debridement, which is not anything noteworthy in that it normally takes four to eight weeks plus to get to complete debridement either way.
SANTYL was not able to achieve median time to wound bed preparation 'cause half the wounds didn't get there. Even with a small N, we still hit p < .05 for time to wound closure. It's 48.4 days for EscharEx and 76 days for SANTYL. You know, given that our EscharEx is highly active, one might think that it could lead to more pain, so we looked at that, and in fact, the pain was virtually identical for both. As we know, venous leg ulcers are very, very painful. That was quite encouraging. Ultimately, between venous leg ulcers and diabetic foot ulcers, projected peak sales in the U.S. reaches $831 million off of a $2.5 billion TAM. That's the 4 million ulcers.
About 72% of them require debridement. From a pricing perspective, we benchmark against SANTYL. We've been guided by payers that we could take as a floor a 15% price increase over the total cost of therapy and a ceiling of around 50%. We model it somewhere in between, and that number, when it all comes down, along with the 22% of the market we anticipate that we'll get to $831 million. We're gonna do the same analysis using pressure ulcers this year. Sometime this year we'll have a revised number, and that $831 million will look even better.
From a strategic timeline perspective, just as a review, again, busy times, this year the big endpoint for us will be the interim assessment for our phase III, the last patient going in, and of course, the removal of any capacity constraints with regard to NexoBrid. The year after we'll have the full-on results and make a filing, the year after that, we should be hopefully in the market with EscharEx sales. With that, I'll open up to any questions.
Thanks, Barry. It was a tremendous presentation, and you're battling against some tech issues as well. Wanted to just ask a couple questions on EscharEx. Just maybe to start, I mean, there's a NexoBrid experience, you know, not product, but burns or wounds too, and there's great efficacy there and early commercial traction that's growing in the United States. The EscharEx value kick really is just the generator in the wound care clinical community around the EscharEx is considering when you around the same product and I think what's well known to be questionable efficacy.
Yeah. Sorry, what was the question?
Basic, just the buzz that's being generated around EscharEx so far today. I know you're in the midst of clinical trial. What's the anticipation? Let's just talk EscharEx and there's some demand that's being created.
You know, we're at each year of the big annual wound care symposium, a couple of months. We always have a presenter. We'll do a symposium, a room, and tell people. I think one of the exciting things if you're a clinician is that there have been phase II, maybe phase III in the past, and they never hit the finish line. This is due to trial design and the demand by the FDA to have a closure endpoint. Since we have facilitation of wound closure, it allows for tried and true products that are already approved to do the closing part. All we need to do is do our part and have theFrom even say so a level of confidence that this product is gonna get past the finish line and make it to the marketplace.
Specifically with regard to they've used SANTYL now for days. We live in a litigious environment in the U.S., so there is a drug on the market. People write for that drug to make sure it's chart. You know, when clinicians find out that the alternative that does in four is what the existing legacy drug does in months, it's exciting to them. From a perspective, I don't remember if this is up there or not in Qs, but number of the aberrations with all the key global wound care players, Mölnlycke, Coloplast, ConvaTec, MiMedx, they're all SD, they're all helping to support our clinical study by providing products that are necessary to use. What they get in return is sort of a seat at the table building a relationship with us.
It's very validating, you know, to the, to the ultimately the value of the asset. $300 from San very number million in this space, something that can't be ignored.
Framed that up nicely. If review the enrollment pace of the value study and, you know, the cohort, it sounds like you're very comfortable with enrollment completion timeline. Are there learnings just in selection or, any other within the clinical trial that you can report on?
You know, as you know, at the beginning of the year, we pushed our expected date back a little bit, and the biggest component of that was less a protocol learning and more that we had some issues in Europe getting everything lined up. There's a product that we're using as part of our standard of care that wasn't approved in Europe, so we had to do some special things to get the product into the countries and for use in the studies.
From a learning perspective, we certainly have captured a few things where we're being very specific about the inclusion and exclusion criteria 'cause at the end of the day that's, you know, we want to have patients come into the study that are hard to heal, and that will, we know based on our phase two data, will result in a, in a, in a good result. There's some things that we have learned, where we've made some tweaks to the protocol, those things are coming online in the coming weeks. Those, you know, will have an impact as well. Getting Europe done and online is the thing that has been able to push our numbers to where they should be.
Great. Just from a, you discussed building out capacity, manufacturing expansion, how are you thinking about the excess capacity as we get into that 2028 and beyond period. I think you may have detailed some of this in the presentation, just to review, how are you guys and, you know, what capacity will you have, say, in 2030? Can you support a $200 million plus ramp?
I think, you know, in the initial launch phase, I think we're gonna be good to launch as we have. You know, as it gets into the hundreds of millions of dollars, there'll need to be more capacity that's built. There's a couple of different ways that we're thinking about it. You know, one potentially could be outside of Israel. I know that there's a desire to have a plant in the U.S. The U.S. government has given as part of their grant funding some money to start speccing out a place in the U.S. It's in their interest to have NexoBrid made here, so potentially, you know, piggybacking into that effort, you know, scaling up into Israel. So there we will have to, you know, address that as things go on.
For the initial couple of years, we're probably good to go as we are.
One last one just on the peak central breast cracks in that $800 AMSA you guys have put on the tape could be some conservatism, and I think you may have been signaling that during your presentation and your team in previous discussions. How should we be thinking about kind of upside to that peak sales number, and what would drive that, you know, north of $1 billion or even further?
I would say the two places where we're conservative that do have a, as you said, a likelihood that will go higher. One is that it only accounts for venous leg ulcers and diabetic foot ulcers. We'll add pressure ulcers into that and I don't know the number yet, but it's gonna go, if you were to split venous and DFU into that 831 and then attach that same number to get to the other third of the pie, it could potentially be in that kind of range, give or take. The other one is on the pricing, right? Because we're guided towards a floor and a ceiling of how much of a premium we could take over SANTYL.
In our model, we kind of split the baby, and we're in the middle. That ceiling is gonna be based on the HEOR outcomes that we get, and we know that if we're closing these wounds substantially faster, it's in the published literature how much a wound costs every week that it's open with a leg ulcer. We'll be able to save facilities a lot of money, and we feel that we'll be able to get closer to that top-end range. We won't know until we see all the data at the end, but that's definitely an area to add to the top.
Well, excellent. Thank you so much for presentation, the Q&A session here, The TD Cowen team sends our best to the MediWound team over in Israel and open for their .
Thank you. Appreciate it.