All right, thank you everyone for joining the Oppenheimer Healthcare Conference. We're on day two here. My name is Frank Brisebois. I'm one of the biotech analysts at the firm. The next presenting company here is MediWound. From the company, we're lucky enough to have CEO Ofer Gonen to present. Thank you, Ofer, for coming. I think what we'll do in terms of format here is a fireside. If you want to send in questions in the Q&A, feel free to do so. If not, you can also email me. With that, you know, thank you, Ofer. You know, I know it's busy times here. We just saw some news hit on your side as well. Maybe just to start, just a little brief background on yourself and MediWound.
Thank you, Frank, and thank you for inviting me to this session. I'm Ofer Gonen. I'm the CEO of MediWound. I've been doing that for the past three years. My background is 20+ years in leading global life sciences companies. I'll be happy to answer your questions today. A few words about the company itself. MediWound is a biotech company specializing in innovative tissue solutions using enzymatic products as non-surgical treatments for severe burns and chronic wounds. Maybe let me highlight a few key points. Our enzymatic technology is well validated, supported by 14 successful clinical trials, and it receives approvals both from the FDA and the EMA. We have an approved drug for burns, NexoBrid. It is already generating revenue and gaining traction on the market. In our pipeline, we have EscharEx.
EscharEx is a phase III product targeting chronic wounds, addressing a lucrative $2.5 billion market opportunity. Additionally, we have built strong collaborations with major players in the markets, including Vericel, Mölnlycke, Solventum, and the U.S. Department of Defense. With over $44 million in cash, we have all the resources needed to execute all our strategic goals.
Okay, great. That's a good overview. I want to spend most of the time on EscharEx. First, I just, on NexoBrid, you do have nice revenue coming in. I just, can you just help us know the current status of the launches in the U.S. and Japan here?
The demand for NexoBrid is very strong, and our revenue is capped only by our ability to manufacture. In fact, the actual demand for NexoBrid is three times higher than what we can currently produce. In the United States, Vericel is making progress in commercializing NexoBrid. More than 50 burn centers have already placed orders for NexoBrid. The feedback, which is very important from the burn centers and from the burn surgeons, has been very, very positive. In Japan, the performance of KAKEN Pharmaceutical is outstanding. They are leveraging their presence in 600 hospitals to generate quite impressive sales. In Europe and Israel, due to the inventory constraints, we have a limited stock, and we focus on supplying NexoBrid primarily to emergency stocks.
What, you know, in terms of the, you talk about the supply and the demand, when will the new GMP facility be operational and supply kind of be managed globally here?
As I said previously, the demand for NexoBrid is increasing due to several factors. First of all, we have two major market launches. It is the United States and Japan. We have a growing governmental interest. We also expand some indications, including pediatrics and military use. We have completed the construction, as we guided, of our new GMP manufacturing facility. Now we are in a phase which is called commissioning. We anticipate achieving full operational capacity by the end of this year, 2025, and the regulatory approvals to follow in early 2026. This facility will increase our production capacity sixfold, and will enable us to meet the global demand.
Okay. On the EscharEx side, can you just touch on the news, big news this morning? You're starting the trial. Just help us understand maybe the trial, what it is, previous data, the study design, just an update on the news that just hit.
Yeah, this is a very important milestone for us. As you can imagine, EscharEx is the major value of our company. We made a lot in order to make this trial happen. This phase III study closely mirrors the design of our successful phase II studies. It gives us very strong confidence in our execution and expected outcomes, in the expected outcomes. The trial is a global trial, multi-center, prospective, randomized, double-blind, placebo-controlled. It has an adapted design. It will be conducted in 40 centers across the United States and Europe. The study will include 216 patients that will be randomized one-to-one to receive either EscharEx or placebo. We have two co-primary endpoints. One of them is the incidence of complete debridement, and the second one is the incidence of complete wound closure. We have an interim sample size assessment.
It will occur after 65% of the patients complete the study. This significant milestone is expected in mid-2026. In this interim assessment, you should expect two outcomes. One, the trial is complete as designed, and we do not need to add additional patients, or additional patients are enrolled to reach the goal of 90% probability of success.
Okay. That's the next update on that side. You know, why should investors feel so comfortable based on prior data as to why this is very de-risk here?
Yeah, we have, if you look at the, first of all, as I said, MediWound succeeded in 14 out of 14 clinical trials across a few indications, but most of them look the same. It's removing the dead tissue from the wound. Specifically in this trial, we have two co-primary endpoints. The first one, we have 99% probability of success, which is the debridement, which is very similar to eschar removal in burns. In all the trials, we showed very consistent results. This is the first endpoint. The second endpoint is actually our ability to facilitate active wound closure. We look for previous studies. EscharEx is doing so after 11 days, while for placebo, it takes almost forever. This trial is 84 days.
In the previous trial, the wound bed preparation milestone was achieved by the placebo only after 85 days, which means in this very significant endpoint, EscharEx has 74 days of head start, and the closures will be done mechanically, which is forced by the protocol.
Okay. Can you help us understand, so that's for the trial that's starting is VLUs?
Yeah.
Can you just help us understand VLUs and DFUs and maybe, you know, why not do it at the same, the difference between them and what's maybe easier to get good readouts on?
Venous leg ulcers, if you look at the market, you can see that both wounds are very significant. Also, if you look at SANTYL's revenue, SANTYL is the drug that we are competing with. You can see that the majority of the revenue are those from these two wounds. Unfortunately, the FDA doesn't give you a label which is called debridement of chronic wounds. You need to have a phase III study for every indication. We took the market with the largest unmet medical need, which is VLUs. These patients are, these wounds are extremely painful, so you cannot debride them with a knife. The only available treatment now is topical. Since the current topical treatments are so slow, NexoBrid will be the only solution. The second to go is diabetic foot ulcers. We secured EUR 16.25 million in funding from the European Union.
This funding actually will accelerate our development of EscharEx to these wounds as well. We're working on a phase III trial now. We will speak with the regulatory agents in 2025, and we will initiate the study in 2026.
Okay. Perfect. It's very organized right now, everything that's going on at MediWound. Can you help us understand, for people that aren't that aware of the field, what these partnerships mean and how they came about? Because you seem to have a lot of partnerships with real leaders in this space. You know, why do that during the trial? Do you keep the economics to yourself? What's their involvement in the company?
Yeah. After we announced the head-to-head data versus SANTYL a year ago, MediWound became a very interesting company. All the large players were interested in EscharEx, knowing its clear advantage over SANTYL. We thought that it is not the right time now to do something strategic around it, but we wanted to keep those large players close to us. What we did in the phase III study to support our venous leg ulcer phase III study, we have established a strategic research collaboration with Solventum, Mölnlycke, and MIMEDX. Those industry leaders will provide their products to ensure consistent wound management across all study sites, and it will optimize the patient outcome. They will bring us the best products. The care of those patients is going to be excellent across both arms.
We will not be in a situation that sometimes placebo patients get an extraordinary treatment while an EscharEx patient gets mediocre treatment. All of them are getting the best care possible. In that way, the advantage of EscharEx will be very clear.
The way you brought this up, you just talked about the head-to-head with SANTYL data. Can you remind people exactly what that showed? I think you touched on the size of the market and the size of the revenues of SANTYL, but I think it is very important to try to understand what EscharEx can actually do here. Can you remind us of what that head-to-head data showed?
We had head-to-head data from our first two studies, EscharEx versus the non-surgical standard of care. We compared the patients that were treated with EscharEx versus the patients that were treated with SANTYL. The gap between the two arms was amazing. If we look at the primary endpoint, which is complete debridement after two weeks, we saw 63% with EscharEx and 0% with SANTYL. Zero with SANTYL is not something surprising. SANTYL does not debride wounds in two weeks. It is a clear advantage. Also, if you looked at the additional endpoints, such as wound bed preparation, which is a primary endpoint in our phase III study, EscharEx, 11 days, SANTYL, it was more than 60 days, head start of 50-something days. If you look at pain, the main advantage of SANTYL is that it is painless.
This is why it is prescribed a lot. You saw that the pain profile of both EscharEx, although it is extremely potent and active versus SANTYL, the pain profile was similar. What we saw, that we have a drug that looks like SANTYL, it is designed to do the same as SANTYL, but it is very quick. If you look at it and then you analyze the market, you will see that there are around 4 million patients that suffer from VLU and DFU. Of those, 3 million require debridement as part of the treatment. If you look at the base pricing of $850 per course of treatment, you see that we are targeting an addressable market of $2.5 billion.
Based on the market research that was done, EscharEx's ability to achieve debridement in five to six applications compared to eight to twelve weeks with the competitor, it positioned it as a highly differentiated solution. This is why we expect EscharEx to achieve 22% of all the debridement market, which means $725 million in peak sales, which makes it the largest, I think, yeah, the largest brand in wound care ever.
Okay. Okay. That's super helpful. Is there another head-to-head study that you're kind of running now in a phase II?
Yes. We also announced that we are doing another phase II trial, which is a prospective study. We will use that to further validate the superiority of EscharEx and also to support our BLA. Our goals in this study are threefold. One, to strengthen the clinical evidence conducted and to show it in a real analysis, a priori analysis that we are way better. Two, to expand the dataset that we generated in order to have something, a robust evidence that will support the market access and pricing discussions as we move forward to commercialization. Lastly, we also want to include IRUXOL. IRUXOL is the collagenase brand in Europe. In the U.S., it's SANTYL. In Europe, it's IRUXOL. We want to include it to assess EscharEx's competitive positioning in Europe as well, since we are developing it globally.
Okay. No, that's helpful. Remind us, it's the same API as NexoBrid, which actually makes it kind of de-risk for EscharEx. Remind us what the IP is on the, you know, the product.
We have an IP for EscharEx until 2039. This product has a much, much more significant protection. First of all, it's a biological drug. You have 12 years of exclusivity after launch. If you assume a launch in 2028, we see we have a protection until 2040, which is longer than the patent. On top of that, it is a biological, botanical product. FDA has a guideline of how to develop generics for botanical products. It is so complicated, it is not surprising that no one did it in the past. Maybe if it becomes a billion-dollar product, it will justify the efforts and the phase III studies that are required. There will be a competition, but we are speaking only after 2040. Until then, EscharEx is expected to dominate the market.
Okay. Okay. Great. I think, I forget when it was, I think it was just early January or I think it was pre-JP Morgan that you had a KOL event to kind of discuss, you know, the phase III for EscharEx. Also, it was really interesting to hear the KOL speak about the market and SANTYL and the unmet need and the time it takes. From your perspective, what were the big takeaways from that KOL event for you guys?
Yeah. Okay. The KOL event had participated there, Dr. Rob Snyder, Dr. Vickie Driver, and Dr. John Lantis. They gave their perspective on the EscharEx phase II data, the data that is already published, our phase III study design, and the commercial opportunity of EscharEx. The key takeaways were the phase III studies were robust and showed consistency because we had three phase II studies. All of them we showed the same. The phase III study is designed for success, and it is extremely de-risked because it takes into account all what we saw in those three phase II studies. They also mentioned that DFU and VLU debridement is a very large opportunity.
EscharEx is well positioned to disturb the market because it's not only it is better than SANTYL, it also gives those physicians finally a solution that is better than a knife, and it is not painful.
It almost seemed like SANTYL, you know, I was always wondering about the head-to-head necessity to show the superiority, but everyone knows SANTYL just doesn't work quick. I feel like they, it was interesting to see that they didn't really necessarily need to see it. They kind of knew if this works fast, it is superior, period, for these patients. That was interesting.
Let me comment to this one. First of all, FDA didn't want us to compare to SANTYL because they said it is not approved for efficacy. Second, when you spoke, I think it was your question, by the way, when someone asked them about the, what do you need to show in order to be better than SANTYL, they said, we know SANTYL for 60 years. We know it takes two months, three months in order for it to do something. If you bring us a product that debrides a wound within two weeks, there will be no question, and we will switch to that. This is why we did the phase III study at the minimum requirements that needed in order for us to just cross the bar. After that, we believe we'll be able to take over this market.
Okay. In terms of the market, you talked about it, the 4 million, then 3 million debridement, and then you get your 20%. Just can you go over that one more time, just slowly, just to really understand? Because it seems like there's a lot of debridement that's done that's not enzymatic as well. Just to better feel for like what is that TAM and how you get to that, we'll dig into that a little bit.
Okay. Unlike burns, in burns, it's very easy, very easy to explain. Most of the procedures are being done with a knife. Here, it's a little bit more complex. The numbers are much larger. Just for comparison, you have 40,000 burn patients in the United States that are hospitalized, while you have 4 million venous leg ulcer and diabetic foot ulcer patients in the United States. We're speaking about the market, which is 100-fold larger. Of those, 3 million require debridement as part of the treatment. Those 3 million, only 18% is done by enzymatic debridement due to it's very easy to use, it's very safe, but due to lack of efficacy, almost 50% of the debridement procedures are being done with a painful scalpel with a knife. Okay?
As I said, we are looking at SANTYL's price with a very small premium after discussing it with the insurance companies. $850 per course of treatment, you will, and you multiply it by the number of patients that are available for debridement, you get to $2.5 billion. The advantage that we have over SANTYL is clear. Also, when you think about 50% of the market that's being done with a knife, patients hate it, physicians don't like it. Almost 20%-30% of them will also switch from a knife to EscharEx. This is why we believe that the market will go from 18% enzymatic debridement to 30% enzymatic debridement. Based on the market research that was done, SANTYL remains a player in the market due to many, many reasons and considerations of all kinds of care settings.
The estimations will be that 22% of this large market will be owned by EscharEx.
Okay. The market can grow. And when you talk about over $350 million from SANTYL in terms of peak sales, do we know what market penetration they had of the enzymatic debridement?
Yeah, they have the enzymatic debridement, they own the enzymatic debridement. This is $375 million in revenue in the United States only. They own the space. It has a lot of advantages. The only disadvantage is that it takes forever, almost like or even similar to just wet dressing and a process that takes a lot of time.
Yeah. Okay. Interesting. And then when you talk about, is this something in terms of customers, you know, on the commercial front, is this hospitals? Is there government funding just because of the military side of some of these wounds? Who are the main customers for this?
Again, this year, we're going to do a very thorough market access study with one of the largest consulting firms in the United States because this market is fragmented. There are many, many, many customers. It's not like burns. You have burn centers, 120, 130 burn centers in the United States. That's it. Here you have the hospitals, you have acute care, you have wound clinics, you have nursing homes. Each of the players has a different strategy and a different motivation. When we look at the market today, we see that there is reimbursement. Some of the people are using the reimbursement, but also there are DRGs, also there is bundling. Also, if you look at the Smith+ Nephew revenue, they are split between all kinds of avenues, and we need to get to dig more into the details in order to optimize our situation.
Okay. And then we went through a lot there. You know, the NexoBrid, you've got capacity that's growing. You've got EscharEx. You're starting a phase III. For investors here, we're just starting the new year. The markets have been interesting, to say the least, been a little messy. How, you know, what are the main milestones? If someone was to say, what should I look at? I've heard about an interim look in 2026. Other than that, what else should we expect from you guys?
We have several key milestones ahead that will drive both our clinical and commercial progress. First of all, of course, let's look at the clinical side. Our phase III study is now, I can finally say that it is underway. We expect the interim readout, as I said, mid-2026, and the completion of the study by the end of 2026. We are also preparing to launch a phase III trial for diabetic foot ulcers, as we said. That way, we will expand the pipeline and expand the potential market to the numbers that we discussed. On the manufacturing front, we are about to submit the regulatory submissions for the FDA and the EMA. It is planned for late 2025, and we expect the approvals for manufacturing facility early 2026.
If we stay on track with these timelines, it will not only support NexoBrid in the United States, in the launch in the United States led by our partner Vericel, but also it will ensure that we can meet the global demand in other territories.
Okay. Perfect. You mentioned your cash position. Is this close, like how much does this trial cost? What is the, you know, are the expenses supposed to really ramp up here? Like where do you stand financially for these trials?
We're quite in a good place financially. Why is the $25 million PIPE that we raised mid-last year, led by the second largest advanced wound care company in the world, Mölnlycke, put us in a great position. We have more than $44 million in cash. We also have additional $16 million to be invested by the European Commission to fund the clinical trials for diabetic foot ulcers, which means $60 million. On top of that, we have more than $30 million in warrants that are deeply in the money, and they're supposed to be exercised in less than a year. All in all, if you look at a trial, at a program that will cost $30 million only, the facility expenses are almost done. The NexoBrid avenue is profitable. It's a very unique position to be, and we can make it through profitability.
You have been, remind us when you started as CEO and why this is probably the most exciting time to look at MediWound from your perspective here.
When I joined the company, I think one of the first people that they spoke with was with you. I told you, listen, there is a huge anomaly here. There is a product that is very close to be approved. No one believed that it will be approved in the FDA due to the complexity nature of the product. The market is huge. We are saving people. The only thing we need is to raise enough money to make us through the finish line. Also, we need to raise money in order to build a manufacturing facility to support the potential growing demand. We did all that. We raised around $90 million in the past couple of years, and it made us, and it brought us here to the great position that we stand now.
Excellent. All right. Ofer, is there anything else I should have asked or did we hit on most?
Yeah, there were some questions, but I'm not going to tell you.
Okay. Excellent. Perfect. Thank you very much.
Thank you so much.