MediWound Ltd. (MDWD)
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TD Cowen 45th Annual Healthcare Conference

Mar 5, 2025

Josh Jennings
Analyst, TD Cowen

We're going to keep moving down the medical devices track with a, not officially a medical device, company, but, a fantastic company, MediWound. We're excited to have Chief Executive Officer Ofer Gonen joining us here. Thank you for coming to Boston. We're looking forward to the presentation and learning more about this, exciting growth opportunities in front of you.

Ofer Gonen
CEO, MediWound

Josh, Boaz Gur-Lavie, it's a pleasure to be here collaborating with Cowen. I will give you a short presentation about MediWound and answer some questions. This presentation, as you can imagine, will include some forward-looking statements. Let me start with saying a few words about the company. Our company is very unique relative to our size. First of all, our technology is validated. It's not rocket science that sometime will work in the future. We have 14 successful clinical studies. You can see our data published in the best journals available. Our product, our first product, is approved in more than 40 countries around the world. As a small company, we're very happy to be able to collaborate with the largest advanced wound care companies in the world. Some of the collaborations are commercial ones. The others are R&D collaborations.

What you can see here is that all the large companies are interested to be associated with our technology. If there are large wound care companies that you do not see in this slide, probably you will see them later down the road. We have $44 million in cash, which means that we have the ability to fund all our objectives. What we basically have is one product which is approved, generated $20 million in revenue in 2024. We have a lot of demand for this product. Actually, the demand exceeds the ability to manufacture threefold. We will speak about it. Based on this, the same technology and basically the same API, we have another product that addresses a much larger market, market of $1.5 billion addressable market. Let's say a few words about our technology.

We were able to formulate a mixture of proteolytic enzymes that are derived from pineapple stems. It's a botanical product, botanical biological product, very complicated. Only three such products were approved ever by the FDA. When you apply this product on damaged tissue, burn, it can be a wound, one application, a couple of applications, you can see that it is able to cleave only to the necrotic tissue, only to the non-viable tissue. It removes it. The alternative is horrible. In order to do that without our drug, we need to have a very sharp knife. We need to have very sophisticated healthcare professionals and to take it off. The differences are unbelievable. As I mentioned, we have two products. The first one on the left is Nexobrid. Nexobrid is a drug for eschar removal for severe burns.

In order to remove eschar in burns, this was a horrible image on the left. This was the standard of care in the United States until one year ago. This was the standard of care in Europe until three years ago. We replaced all that with our topical application. It is an orphan drug. It is approved across many countries, and it was launched in the United States by Vericel only last year. There are around 40,000 patients in the United States that are hospitalized in the United States with severe burns. The majority of them require eschar removal, and these are the potential customers of Nexobrid. Look at the image on the right. We have our second pipeline product, which is based on the same active pharmaceutical ingredient. Not based on the same, actually, it is the same active pharmaceutical ingredient.

Different formulation, different concentration, but it targets much larger market. Instead of 40,000 patients hospitalized in burns in the United States, we are speaking about 4 million patients that suffer from the indications that we are treating. Means we're speaking about a market which is 100 times bigger, patient population-wise, around 10 times larger if we speak about expected revenue. This product, we concluded three phase II studies. All of them were very successful, and we just announced that we initiated the first restudy with the first application, venous leg ulcers. We'll discuss it later in this presentation. Again, we are very proud that although we are a very smart and small company, look at this pipeline that we have. It's a BLA product, so very expensive to get it to the finish line.

As you can see, for Nexobrid, the drug that we have for severe burns, the two largest indications, eschar removal for adults and for the pediatric population, it's done. It is approved. It's generating revenue, and this product is profitable. On top of that, we have additional two indications funded by the U.S. Department of Health and the U.S. Department of Defense. Both products are for expanding the indication. Some of them are for battlefield burn injuries, and some of it is for blast injuries. Nexobrid as a whole is a very profitable product for MediWound, and we are looking forward to increasing the revenue gradually. EscharEx. EscharEx is the main product that we have. I think it consists of something like 85% of our potential. You can see that we started the phase three trial for venous leg ulcers. We just started it.

We'll speak about the timeline in the next slide. The second indication for diabetic foot ulcer, we'll start a year from now. We have a lot of milestones. We have near-term milestones and long-term milestones. Let's start with Nexobrid because it's easier to digest. We just announced that the U.S. government recognized that it is quite crucial to have a facility in the United States to support this country in case of mass casualty incidents. They funded some activities in order to build a facility in the United States. We anticipate additional collaborations with other governments. Maybe I'll show you a couple of slides about that. We intend to finish scaling up our manufacturing facility by the end of this year and everything, and we will be without restrictions in 2026.

All this information that I mentioned here about Nexobrid is embedded in this slide, which shows our guidance. We already announced that we sold in 2024, we had $20 million in revenue for Nexobrid. In 2025, we anticipate to have $25 million. In 2026, more than $30 million, and it will grow, gradually. These revenues are basically supported by building a new manufacturing facility. This year, we announced already that we finished building the facility. We expect to have full capacity availability by the end of 2025. We need to get two approvals. We need to get the EMA approvals. We need to get the FDA approvals. Assuming that we meet those timelines, EMA by the end of 2025, FDA mid-2026, we can quite easily meet the revenue guidance that we have here. Now let's move to EscharEx.

EscharEx, we are going to have a very exciting year coming. Actually, we just started it. We started the phase three study, the largest, most comprehensive phase three study in venous leg ulcer patients. We started it a couple of weeks ago. Look at the timelines. By mid-2026, we will have interim assessment of this large trial. This trial will include 216 patients. We'll be randomized one-to-one EscharEx versus placebo. Our expectation is that by mid-2026, we'll be in a position to look at the data and see whether we have more than 90% probability to succeed, to have positive primary endpoints. If we are not at the 90%, we will recruit additional patients in order for us to be sure that we are able to meet the endpoint. Be sure it means to maintain the 90% probability.

As I told you, MediWound succeeded in all the 14, all the 14 clinical trials that were conducted to date. We do not have any intention to meet the specific endpoint, which is the specific catalyst, which is the most important for in the life of the company. In between, we have additional small studies, studies that are quite trivial, PK study, human factor study, another head-to-head study versus collagenase in order for us to be able to maybe charge more once EscharEx is approved for venous leg ulcer patients. No doubt that the most important milestone that we have is the interim assessment in mid-2026. If everything goes well, by the end of 2026, we should finish the study and be one year ahead of a very significant launch. Let's speak about the financials. Financials, we have $44 million in cash in the end of the year.

We have no debt. On top of that, we also won funding from the European Union that will fund our phase three study with diabetic foot ulcers. If you add these numbers, it's around $60 million. On top of that, we have additional $34 million in warrants that should be exercised in the next year and a half. All of them are dipping the money. We have enough cash to support all of our objectives going forward. We generated $20 million in revenue, and our intention is to generate $25 million in 2025. Let me tell you why we're so happy to be in a position that we have those two drugs.

The first one, Nexobrid, we discussed the photo here on the right, very painful, very traumatic, a lot of blood loss, a lot of wound care specialists that need to treat the burns if you don't have a solution of Nexobrid. Actually, without having such a solution, the burn never heals. We replaced all that in a very rapid topical application. If you look at the palm of the hand on the left, if it was not used with Nexobrid, you can't even imagine how this hand would look like after treatment in the surgical manner. Let me tell you a couple of stories that will show you how important Nexobrid is and why we anticipate that around 50% of our future revenue will be derived from governments around the world. September 11, everyone knows what it is.

It's a story of a, not a small hospital, Hospital Cornell, the United States, in New York. Only 14 burn centers, burn victims were hospitalized after September 11. These 14 patients, four of them died. These 14 patients blocked the whole hospital for two months. Couldn't admit additional patients. They required hiring additional 64 team members in order to treat those patients. 60-something operations, a lot of blood infusions, a lot of reconstructing surgeries, all kinds of things. It took two or three months for only 14 patients. Imagine what happened in September 11. I guess there were hundreds of burn patients. They blocked all the system in the United States. I'm speaking here about one hospital and 14 burn patients. Nexobrid was not available back then. No need to mention. Now let's look at what happened in Israel.

Israel, October 7, the largest terror attack that every single hospital needed to tackle. We had, in the first 24 hours, one patient every one minute was admitted to the hospital. At the peak, every 40 seconds, there was a burn patient that was admitted to the hospital. No one in Israel heard anything that happened in a hospital. We immediately, as a company, reported that we deployed all the Nexobrid, all the Nexobrid inventory in order to support what happened in Israel. Dozens or hundreds of civilians and soldiers were burned, some of them alive. Nexobrid saved many hundreds of surgical procedures. Everything will be published quite shortly. They are collecting all the data of hundreds of patients. No one heard about anything that happened to the hospital system in Israel.

There are something like two, max three burn centers in the United States treated multiples of the 14 patients that we spoke about in the previous slide. Nexobrid is something that saved our country. This is something that we are very proud of. Every country around the world, we believe, will be interested in stockpiling it down the road after everyone sees the results. Having said that, Nexobrid is a relatively modest product. At peak sales, we do not expect it to exceed more than $100 million in revenue for MediWound. EscharEx is our biggest excitement. We are targeting two large wounds. One of them is venous leg ulcers, 1.5 million patients a year. The second one, diabetic foot ulcer, 2 million patients a year. Massive markets without any, any real solution. Again, in order to treat those wounds, first critical step, you need to debride the wound.

Otherwise, it will never heal. We conducted three phase II studies. All of them were very successful. Endpoints were met in a very high, in statistical significance. We show, if you see here on the right, each study showed all kinds of relevant parameters for treating wound care. In the first study, we saw that our drug does debridement and wound size reduction, which is also very important. The second one showed that we also do wound bed preparation and biofilm disruption and bacteria load reduction. Lastly, the largest trial, we focus on the two main, two main requirements for a wound care drug, debridement and wound bed preparation. I'm not going to go through all the data, but as you can see, they are very robust and very consistent. In all the trials, Nexobrid was much, much better. Nexobrid, sorry.

EscharEx was much better than placebo, much better than the standard of care, much better than anything that the market knows. In this slide, you can see why, why we're so attractive. Currently in wound care, there are only two drugs that are available. One of them was approved in the 1960s, Santyl. The second one that is doing something else, it was approved in 1995. That's it. No one succeeded to make it, to make it to the finish line with, drugs for treating chronic wounds. Look what we're doing to our main competitor, which is Santyl. Look at the primary endpoint, incidents of complete debridement. And I'm speaking about EscharEx versus a drug that has a label of debriding wounds. Okay. After two weeks, 63% of our wounds were debrided, while 0% of the Santyl wounds were debrided.

No one is excited from that, from the KOL, from the KOL that were involved, because Santyl is not doing anything in two weeks, and it is well known. Not only that, the primary endpoint of debridement is met, all the other relevant parameters, achieving wound bed preparation, closing wounds, even, patient reported pain. With all of them, we either had a very strong advantage or the products were comparable. Now we are getting ready for the phase three study. The phase three study is going to be a very robust one. We made sure that we collaborate with the largest advanced wound care companies in the world in order to make sure that this trial will be very attractive, not only for us, but both, but also for the medical centers that are involved, also for the patients. They are getting the best ancillaries, best treatments.

Even the placebo patients are going to get better treatment than they usually get. It's going to be in the very highest standard. As I said, we succeeded in all the clinical trials to date. Our plan is to succeed in the most significant as well. How it impacts the market. We got an investment from Molnlycke, which is the second largest advanced wound care company in the world. We got a $25 million investment. The investment was not focused on specific, to do specific things, but one of the warm recommendations that we got is, hey, let's understand the market. We know that it's big. We know that we have 4 million patients. Let's see what is the market share that EscharEx can actually capture once it is approved. Burns is the most simple because in burns, there are only burn centers.

No one treats severe burns at home. No one treats severe burns in a clinic. Only in burn centers. In wounds, without getting into too many details, look on the left. There are wound clinics, nursing homes, acute settings, all kinds of treatments, all kinds of treatment, all kinds of physicians and healthcare professionals with different motivations. We conducted a very thorough market analysis conducted by Alera Health, which is a company which is considered the best in this specific field. They analyzed the market. If you look on the left, you can see that currently Santyl is a very large brand. 18% of the debridement market is done by Santyl. 47% is done by a knife. Still, a knife with all the disadvantages of treating wounds, painful wounds with a knife. After EscharEx, it's going to be on the market.

According to this market research, the enzymatic debridement piece is going to increase quite substantially from 18% today to 30% once EscharEx is launched. Why? I can understand why people who use Santyl might use Santyl or EscharEx. It remains the same. Other modalities, such as using a knife, using maggots, using ultrasound, all kinds of other modalities, if you have the option to take a drug, give it to the patient, use it at home for one week, come back, and the wound is fully debrided and ready for closure, it looks like something which the outcome looks even very conservative, that 30% of the debridement modalities will be done with EscharEx, with the enzymatic debridement. From that analysis, it's basically now just mathematics. Four million wounds, three million required debridement, $2.5 billion market, and the expected peak sales of such a product is $725 million.

There aren't any products in wound care today that are that large. This is going to be the most significant single brand in wound care if we are approved. All the strategic players, all the advanced wound care companies in the world, they're interested in taking over all the environment from prevention, treatments, closure, CTPs. They want to have all their products. No one has debridement other than Smith & Nephew. This is why we are so attractive strategic-wise. Let me summarize how our strategic timeline looks like. We launched EscharEx through various sales in the United States in 2024, raised capital that enabled us to be in a position that I can tell you that I have enough cash to do all our objectives for going forward. We signed a strategic collaboration with the second largest advanced wound care company in the world.

The strategic collaboration, by the way, they have equity investment, and they have a right to participate in a strategic transaction if we decide to do something. If we want to do an M&A transaction, we can't close it without Molnlycke. Knowing that, they don't have a first refusal, but this is, but we need to consider their offer as well. This year is the year of execution. We are going to keep on generating revenue of Nexobrid. As I said, it is quite easy. If I can manufacture, I can sell. I have a lot of demand. We are going to start two phase, one phase three study, one phase two study. We will keep on the collaboration with the U.S. government, and we will finish the, increasing of my of our manufacturing facility.

2026 is going to be our money time results of all the clinical trials, hopefully stopping the trial after an interim assessment, knowing that we have, Blockbuster in our hand. 2027 or 2028, expect EscharEx to be approved. In the first year of EscharEx revenue, we expected to generate more revenue than Nexobrid at peak. This is where we stand. I'll be very happy to answer questions if you have. Thanks, Ofer. I'll hand that the mic to Lam. It looked like, if I'm doing the math close to right, that given that Santyl does $325 million and Nexobrid, I'm sorry, EscharEx was going to be about 2x the, yeah, the percent or 2.5x that you were suggesting pricing very similar to Santyl, despite the fact that the advantages are even more apparent.

I was just wondering if I'm doing the math right and if you could comment on that. I won't be able to correct your math, but first of all, it's not 325, it's 375, Santyl. We are speaking about a premium, modest premium. We had discussions with, with all kinds of insurance companies, and they said that if we have a product with advantage over Santyl, we can charge 15% without them asking questions. What I told you before is that we are doing additional small study, which is EscharEx versus collagenase. We're going to collect their additional data. Then we are going to come to the insurers, say, okay, we are not just debriding, we are also preparing the wound for closure, we are also removing bacteria, we are also removing biofilm. We'll come with all the data and we might be able to charge more.

For MediWound specifically, it is very significant because every dollar that you increase the price, everything goes to the bottom line. According to this analysis, and I think I told it to some of you in the previous meeting that we have, most of the strategic players went through this model. We did not get any rejection. We think it is very, very conservative. It might be larger, but $700 million for a company like us is good enough. Yeah. One follow-up just on that conservatism comment you just laid out there and you shared that with us before, just that 22% conversion rate that the market research kind of set, I think, potentially a floor. I mean, is that the right way to think about it?

I guess in the, in a more bullish scenario, you know, analysis, you know, how high can that conversion rate be? I mean, I would suspect it could be much higher than 22%, but we have not done enough survey work yet. This is something we are now starting doing a very thorough market analysis with a very large company. Hopefully by the end of the year, we'll be able to become more granular. Santyl, although in every parameter looks like we are better than Santyl, Smith & Nephew is selling bundles. There will always be a component of Santyl on the market. Currently, when you look at the outcome of the interview that healthcare professionals were done, still 40% of the physicians will keep on using a knife. I think it's a lot.

I don't see, you know, I just showed, I keep on getting all kinds of requests for treating Nexobrid. Someone has a burn. The COO of the company, I'm getting all day long, a lot of requests. I don't believe that people will keep on using a knife if the alternative is I'll take a drug, I will apply it one week at home, and the outcome will be the same. If I needed to guess, it would be higher. Again, this is the market research. They didn't ask me, they didn't ask anything. They just do it externally, came back with the outcome. Seems reasonable.

I'm not sure if you can pull up the slide just with the timelines of the, of the EscharEx development program, but wanted to, I mean, just, I think we've been clear on this as well, but just to emphasize that, you know, the PK study, human factor study, the DFU, sorry, the head-to-head study versus collagenase, you know, they're not required by the FDA, but they're going to be, you can potentially use that as supportive evidence in the filing, but then also, to drive, you know, payer decisions and, and, and customer adoption. Is that the right way to think about it? Yeah. When you said at the beginning that we are a medical device company, no, it's a, it's we are, we are developing, we are, we are filing a BLA. You cannot treat patients without submitting all the package.

I can't have a negative result in a trial and you say, you know what, I'm not going to submit it to the FDA. Everything is going to be submitted to the FDA. It's important, first of all, to show the safety of the product. It's a product, not a niche product like burns that is supposed to treat, I don't know, 10,000 patients a year. We're talking about a product that's supposed to treat hundreds of thousands of patients a year. Everything, all the safety data is important and it will be conducted in those trials. We need to have a certain amount of exposure of patients. You can't get approval without being thousands of patients should be exposed to the specific API. Luckily, we have the burns, so we are covered also there.

Yes, everything will be submitted, but the most important trial, I don't see a reason why we can come to you in the beginning of 2026, hey, we failed the PK study. It won't happen because we did that for burns. Burns are larger. EscharEx is twice as, the concentration is twice as much. We succeeded in burns, will not fail in wounds. The only binary event, strong binary event we have is the interim assessment for VLU. Actually, one more from Len. Here you go. I think it's worth noting, and I'd love to hear your thoughts at the KOL events that you've hosted. You've had probably two of the top people involved in wound healing as leading spokespeople for your product. Could you discuss that and Dr. Driver and Dr. Lantis's involvement with your company or the studies that you're doing?

First of all, you go to wound care conferences, 50% of the presentation, the papers, everything you speak about is about either it can be CTPs, which is a big issue, and it can be EscharEx. There aren't any new real drugs under development. All the KOAs are interested in being associated with it. We have an SAWC coming soon. It's another large conference. You will see that all the top key opinion leaders are associated. First of all, we are doing the phase three trial in all the large sites in the United States. Our purpose is that by mid-2026, there won't be a physician in the United States that will not hear about the product and know what it does. One word I will say about the Nexobrid.

NexoBrid, before it was launched, very seldom did a kind of a survey between, among, physicians that are burn surgeons. 87% of them knew what NexoBrid is. It's not trivial. We want to be in the same position with EscharEx. In the launch, we will be able to get closer to the $700 million in revenue, very close to the launch. Thanks so much. Thanks so much, Ofer. Great to see you. Thanks for the download.

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