MediWound at TD Cowen Conference: Strategic Insights on Growth

On Wednesday, 05 March 2025, MediWound Ltd (NASDAQ: MDWD) presented at the TD Cowen 45th Annual Healthcare Conference, discussing its strategic advancements in wound care. CEO Ofer Gonin highlighted both the successes and challenges facing the company, focusing on their key products, NexoBrid and EscharEx. While NexoBrid is already profitable, the company is optimistic about EscharEx’s larger market potential.

Key Takeaways

• MediWound anticipates $25 million in revenue for 2025 from NexoBrid, with projections exceeding $30 million for 2026.
• EscharEx is poised for significant growth, targeting a $2.5 billion market with potential peak sales of $725 million.
• The company maintains a robust financial position with $44 million in cash and no debt.
• A new manufacturing facility is expected to be operational by the end of 2025, pending regulatory approvals.
• Strategic partnerships and government collaborations are central to MediWound’s growth strategy.

Financial Results

• Cash Position: MediWound reported having $44 million in cash at the end of the year, with no outstanding debt.
• Revenue Projections: NexoBrid generated $20 million in 2024, with expected revenues of $25 million in 2025 and over $30 million in 2026.
• Funding Opportunities: The company could access approximately $60 million from the European Union for a Phase 3 diabetic foot ulcer study and $34 million from warrants.

Operational Updates

• NexoBrid Manufacturing: Expansion of the manufacturing facility is underway, with full capacity expected by the end of 2025, contingent on EMA and FDA approvals.
• Regulatory Approvals: MediWound aims for EMA approval by the end of 2025 and FDA approval by mid-2026.
• EscharEx Clinical Trials: A Phase 3 trial for venous leg ulcers has started, with interim results anticipated by mid-2026.

Future Outlook

• EscharEx Market Potential: The company is targeting a $2.5 billion market, with EscharEx expected to achieve peak sales of $725 million.
• Strategic Goals: Plans include launching EscharEx in the U.S., enhancing collaborations with the U.S. government, and increasing manufacturing capacity.
• NexoBrid Expansion: MediWound is exploring additional government collaborations for stockpiling NexoBrid.

Q&A Highlights

• EscharEx Pricing: MediWound aims for a modest premium over Santel, with potential for higher pricing based on clinical data.
• Conversion Rate: Market research indicates a 22% conversion rate from other debridement methods to EscharEx.
• Clinical Trials: Additional studies will support EscharEx’s safety and approval, influencing payer decisions and customer adoption.

For more details, please refer to the full transcript.

Full transcript - TD Cowen 45th Annual Healthcare Conference:

Josh, Cowen: We’re gonna keep moving down the medical devices track with a, not officially medical device company, but a fantastic company of MediWound. And we’re excited to have Chief Executive Officer, Ofer Gonin, joining us here. And thank you for coming to Boston, and we’re looking forward to the presentation and learning more about this exciting growth opportunities in front of you.

Ofer Gonin, Chief Executive Officer, MediWound: Josh, for hosting me. It’s a pleasure to be here collaborating with Cowen. Give a short presentation about MediWands and and answer some questions. So 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 forty forty countries around the world. As a small company, we’re very happy to be able to collaborate with the largest advanced volunteer companies in the world. Some of the collaborations are commercial ones. The others are r and d collaborations. But 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 don’t see in this slide, probably you will see them later down the road. We have $44,000,000 in cash, which means that we have the ability to fund all our objectives. And, what we basically have is one product which is approved, generated $20,000,000 in revenue 2024. We have a lot of demand for this product. Actually, the demand exceeds the ability to manufacture threefold.

We’ll speak about it. And based on this the same technology and basically the same API, we have another product that addresses much a larger market, market of $1,500,000,000 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 could be a wound. One application, a couple of application, you can see that it is able to cleave only to the necrotic tissue, only to the nonviable tissue, it removes it. The alternative is horrible. In order to do that without a drug, we need to have a very sharp knife, need to have very sophisticated healthcare professionals, and to take it off.

The differences are unbelievable. So 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 SCAR in burns, this was horrible image on the 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. So it’s 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 forty thousand patients in The United States that are hospitalized in United States with severe burns. The majority of them require eschar removal, and these are the potential customers of NexoBrid. But 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, actually, pharmaceutical ingredient, different formulation, different concentration, but it targets much a larger market. Instead of forty thousand patients hospitalized in burns in The United States, we are speaking about four million patients that suffer from the indications that we are treating. Since we are speaking about the market which is 100 times bigger, patient population wise, around 10 times larger if we speak about expected revenue. In this product, we concluded three phase two studies. All of them were very successful, and we just announced that we initiated the first restudy with the first indication in the leg ulcers.

We’ll discuss it later this presentation. Again, we are very proud that although we are very smart smart smart and small company, look at this pipeline that we have. It’s BLA product, so very expensive to get it to the finish line. So as you can see, on NexoBrid, the drug that we have for severe burns, the two largest indications, test care 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 US Ministry of Health and the US Department of Defense. Both products are for expanding the indication. Some of them is for battlefield burn injuries, and some of it is for blast injuries. So EXO GRID as a whole is a very profitable product for MediWound, and we are looking forward for increasing the the the revenue gradually.

And EscharEx. EscharEx is the main product that we have. I think it consists something like 85% of our potential. You can see that we started the PACE risk trial for venous leg ulcers. We just started it.

We’ll speak about the timeline in the next slide. And the second indication for diabetic foot ulcer will start here 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 US government recognized that this is quite co crucial to have a facility in The United States to support this country in case of mass casualty incidents. So 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 twenty twenty twenty four. We had $20,000,000 in revenue for, NexoBrid. Twenty twenty five, we anticipate to have 25,000,000. 20 20 6, and more than 30, and it will grow gradually.

These revenue 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 twenty twenty five, and then we need to get two approvals. We need to get the IMAP approval. We need to get the FDA approvals, assuming that we meet those timelines.

EMA by the end of twenty twenty five, FDA mid ’20 ’20 ’6, we can quite easily meet the revenue guidance that we have here. So 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 and look at the timelines. By mid twenty twenty six, we will have interim assessment of this large trial. This trial will include two sixteen patients, will be randomized one to one paramex versus placebo. Our expectation is that by mid twenty twenty six, we’ll be in a position to look at the data and see whether we have more than ninety percent probability to succeed, to have positive primary endpoints. And if we are not at the ninety ninety percent, 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, MeriOne succeeded in all the 14 all the 14 clinical trials that were conducted to date. We don’t have any intention to meet this specific endpoint, which is this 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 to for us to be able to maybe charge more once SCRx is approved for venous leg ulcer patients. But no doubt that the most important milestone that we have is the interim assessment in 2026.

Everything goes well. By the end of twenty twenty six, we should finish the study and be one year ahead of a very significant launch. Let’s speak about the financials. Financials, we have $44,000,000 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. So if you add these numbers, it’s around $60,000,000 On top of that, we have additional $34,000,000 in warrants that should be exercised in the next year and a half. All of them are deep in the money. So we have enough cash to support all of our objectives going forward. We we we generated 20,000,000 in revenue, and our intention is to to to generate 25,000,000 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 on the right. Very painful, very traumatic, a lot of blood loss, a lot of wound care specialist that needs to treat burns if you don’t have a solution of NexoBrid. And, actually, without having such a solution, the the the burn never heals. We replaced all that in a very rapid topical application.

And 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 a 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. So September 11, everyone knows what it is. It’s a story of 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 beat those patients, 60 something operations, a lot of blood infusions, a lot of reconstruction surgeries, all kind 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, so they blocked all the system in The United States. And I’m speaking here about one hospital and 14 burns burn patients. NexoBrid was not available back then. No need to mention. Now let’s look what happened in Israel.

Israel, October Seven, the largest terror attack that every sing that a single hospital needed to tackle. We had, in the first twenty four hours, one patient, every one minute was admitted to the hospital. At the peak, every forty seconds, there was a burn patient that was admitted to the hospital. No one in Israel heard anything that happened in the 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 and and soldiers were burned, some of them alive. NexoBrid saved many hundreds of surgical procedures. Everything will be published quite shortly, 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 burns burns centers in The United States, with the multiples of the 14 patients that we spoke about in the previous slide.

NexoBrid is something that saved our country, so this is something that we are very proud of. And 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 relatively modest product. At peak sales, we do not expect it to exceed more than $100,000,000 in revenue for MediWound. EscharEx is our big biggest excitement.

We are targeting two large ones. One of them is venous leg ulcers, one point five million patients a year. The second one, diabetic foot ulcer, two 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 two studies. All of them were very successful. Endpoints were met in a very, high, in in statistical significance. And we show, if you see here on the right, each study show all kind showed all kind of relevant parameters for treating wound care.

In the first study, we saw that our drug does a debridement and wound size reduction, which is also very important. Second one showed that we also do wound preparation and biophilic disruption and bacteria load reduction. And lastly, the largest trial, we focus on the two main two main requirements for wound care drug, debridement and wound bed preparation. So 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 trial, ExoBrid was much, much better ExoBrid.

Sorry. ExoBrid 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 nineteen sixties, Santel.

The second one that is doing something else. It was approved in 1995. That’s it. Someone 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 Santel.

Look at the primary endpoint, incidence of complete debridement, and I’m speaking about Rx versus a drug that has a label of debriding wounds. Okay? After two weeks, sixty three percent of our wound were debrided, while zero percent of the Santill wound were debrided. No one is excited from that, from the KOL, from the KOL that were involved because Santel is not doing anything in two weeks, and it is well known. It’s not only that the primary endpoint of the drive is met, all the other relevant parameters, achieving wounded preparation, closing wound, even patient reported pain.

With all of them, we either had a very strong advantage or the products were comparable. So 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 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 a very highest standard. And 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 impact the market?

We got an investment from, Olikay, which is the second largest advanced wound care company in the world. We got $25,000,000 investment. The investment was not focused on specific, to do specific things, but one of the warm recommendation that we got is, hey. Let’s understand the market. We know that it’s big.

We know that we have 4,000,000 patients. But let’s see what is the market share that S Correct can actually capture once it is approved. Burns is the most simple because in burns, there is 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, wound clinics, nursing homes, acute settings, all kind of treatments, all kind of treat all kind of physicians and healthcare professionals with different motivations. So we conducted a very thorough market analysis conducted by Alera Health, which is a company which is considered the best in this specific field, and they analyze the market. And if you look on the left, you can see that currently, Santill is a very large brand. 18% of the debridement market is done by Santel. Forty seven percent 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 risk quite substantially from 18% today to 30% once EscharEx is launched. Why? I can understand why people who use Santill might use Santill or EscharEx. So it remains the same.

But other modalities such as using a knife, using maggots, using ultrasound, all kind 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 thirty percent of the debridement modalities will be done with, EscharEx, with the enzymatic debridement. So from that analysis is the basically now just mathematics, four million words, 3,000,000 required debridement, two point five billion dollars market, and the expected peak sales of such a product is $725,000,000 There aren’t any products in wound care today that are at 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, closures, CTPs. They want to have all their products.

Someone has the drive and other than Smith and Nephew, so this is why we are so attractive strategic wise. Let me summarize how our strategic timeline look like. So we launched EscharEx through very selling United States Twenty Twenty Four, raised capital that enabled us to be in a position that I can tell you that I have enough cash to to do all our objective for going forward, and 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 and a transaction, we can’t close it without Moli Ki.

Knowing that, they don’t have a first refusal, but this is but we need to consider their offer as well. This year is a year of execution. We are going to keep on generating revenue of Nexo of NexoGrid. 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 US government, and we will finish the increasing of of our manufacturing facility. Twenty twenty six 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. Twenty twenty seven or ’8, expect EscharEx to be approved.

In the first year of EscharEx revenue, we expect it to generate more revenue than XOBLD at peak. This is where we stand. I’ll be very happy to answer questions.

Josh, Cowen: Thanks, Sopher. Yeah. I’ll hand that the mic to Lang.

Glenn: It looked like if I’m doing the math close to right that given that Santill does $325,000,000 and NexoBrid I’m sorry, escrowx was going to be about 2x the percent or 2.5x that you were suggesting pricing very similar to Santill despite the fact that the advantages are even more apparent.

Josh, Cowen: So I

Glenn: was just wondering if I’m doing the math right and if you could comment on that.

Ofer Gonin, Chief Executive Officer, MediWound: I won’t be able to correct your math, but first of all, it’s not 3 it’s not $3.25, it’s $3.75 something. We are speaking about, premium, modest premium. We had discussions with, with, all kind of insurance insurance companies, and they said that if we have a product with advantage over Santel, we can charge 15% without them asking questions. But what I told you before that, we are doing additional small study, which is Escariq versus collagenase. We’re going to collect their additional data.

Then we are going to come with to the insurance said, okay. We are not just debriding. We are also preparing the ones 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. So very more specifically, it is very significant because every dollar that you increase the price, everything goes to the bottom line. So 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 didn’t get any rejection. So we think it is very, very conservative.

It might be larger, but $700,000,000 for a company like us, good enough. Yeah.

Josh, Cowen: One follow-up just on on that conservatism comment you just laid out there, and you shared that with us before, but just that 22% conversion rate that the market research kinda of set, I think, potentially a floor. But, I mean, is that the right way to think about it? And I guess in the more bullish scenario analysis, 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.

Ofer Gonin, Chief Executive Officer, MediWound: So so, again, this is something we are now starting doing a very thorough market analysis with a very large company, and hopefully by the end of the year, we’ll be able to become more granular. Santil, although in every parameter, looks like we are better than Santil, is selling bundles. Right? So always, there will be a component on of the market. Currently, when you look at the outcome of the interview that professionals were done, still 40% of the pay 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’m keep on getting all kind of requests for treating someone has a burn. Let’s see over coming. I’m getting all the all day long a lot of requests. I don’t believe that people will keep on using knife if the alternative is I’ll take a drug, I’ll get a flight, one week at home, and the outcome will be the same.

So if I needed to guess, it would be higher. But, again, this is the market three shots, and they didn’t ask me they didn’t ask anything. They just do it externally, came back with the outcome. Seems reasonable.

Josh, Cowen: I’m not sure if you can pull up the slide just with the 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 the PK study, human factor study, the DFU, sorry, the head to head study versus collagenase, they’re not required by the FDA, but they’re gonna be you could potentially use that as a supportive evidence from the filing, but then also to drive payer decisions and customer adoption. Is that the right way to think about it?

Ofer Gonin, Chief Executive Officer, MediWound: Yeah. So again, when you said the beginning that we are a medical device company and always it’s we are we are we are filing a BLA. You cannot treat patients without submitting all the package. I can’t have a negative result in the trial, and you say, you know what? I’m not going to submit it to the FDA.

So everything is going to submit it 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, ten thousand patients a year. We have a product that should supposed to treat hundreds of thousand of patients a year. So everything, all the safety that that is important, it will be conducted in in those trials.

We need to have a certain amount of exposure of patients. We can’t get approval without being thousand of patients should be exposed to the specific API. Luckily, we have the burns, so we are covered also there. But, yes, everything would be submitted, but the most important trial, I don’t see a reason why we can’t come to you in beginning of twenty six. AA, we’ve failed the PK study.

It won’t happen because we did that for burns. Burns are larger. ETHCorex is twice as, the concentration is twice as much. So we succeeded in burns in not failing wood. But the only binary event, strong binary event we have is the interim assessment of video.

Josh, Cowen: Actually, one more from Glenn. Here you go.

Glenn: 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 Doctor. Driver and Doctor. Lantus’ involvement with your company or studies that you’re doing?

So,

Ofer Gonin, Chief Executive Officer, MediWound: first of all, you go to one 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, Escorex. There aren’t any new real drugs under development. All the KOS 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. So our purpose is that by mid twenty twenty six, there won’t be a physician in The United States, not hear about the product and know what it does. One word I will say about, about NexoGrid NexoGrid, before it was launched, very did a kind of a survey between, among physicians that are surgeons.

Eighty seven percent of them knew what NexoGrid is. It’s not trivial. We want to be in the same position with EscharEx. So in the launch, we will be able to get closer to the $700,000,000 in revenue very close to the

Josh, Cowen: Thanks so much, Ofer. Great to see you. Thanks for the download.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.