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MediWound Ltd. (MDWD)

Q4 2015 Earnings Call· Mon, Jan 25, 2016

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Transcript

Operator

Operator

Good day. And welcome to the MediWound Fourth Quarter and Year-End 2015 Financial Results Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Anne Marie Fields, Senior Vice President with LHA. Please go ahead.

Anne Marie Fields

Management

Thank you, Maria. Good morning. This is Anne Marie Fields with LHA. Thank you all for participating in today’s call. Joining me from MediWound are Gal Cohen, Chief Executive Officer; and Sharon Malka, Chief Financial and Chief Operations Officer. Before the opening of the U.S. stock market today, MediWound announced financial results for the fourth quarter and full year ended December 31, 2015. If you have not received this news release or if you would like to be added to the Company’s distribution list, please call LHA in New York at 212-838-3777 and speak with Carolyn Curran. Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of MediWound. I encourage you to review the Company’s filings with the Securities and Exchange Commission including without limitation, the Company’s forms 20-F and 6-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, January 25, 2016. MediWound undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that said, I would like to turn the call over to Gal Cohen. Gal?

Gal Cohen

Management

Thank you, Anne Marie. Good morning to our listeners in the U.S. and good afternoon to those joining us from Israel. Thank you all for your interest in MediWound and for participating in today’s call. As a company, we made great progress throughout 2015, in particular with our commercial and clinical programs, which I will detail for you during today’s call. We achieved many milestones during 2015, including the treatment of hundreds of severe burn patients with NexoBrid in more than 70 burn centers across Europe. We significantly increased awareness, interest and use of NexoBrid through the exposure of then for more 90 abstracts and award winning poster presentations at premier international burn conferences in the U.S. and Europe, as well as from new scientific and clinical reviewed papers. In addition, we initiated our U.S. Phase 3 study of NexoBrid to treat severe burns. In addition to our progress with severe burns, we have two exciting opportunities ahead as we enter into two new markets. One is the market for preparedness of mass casualty incidents with NexoBrid; and the second one is the market for chronic wound care with EscharEx. We are well-positioned to advance our synergy in each of these markets in 2016, which I will discuss in greater detail later in the call. But first let me turn to a review of our ongoing commercial progress with NexoBrid in Europe. By the end of 2015, we had trained burn centers in more than 100 hospitals across Europe and we have been working with these centers to integrate NexoBrid use into their workflows. About 70% of those trained burn centers have started to treat patients with NexoBrid, resulting in an increasing number of patients being treated with NexoBrid every quarter. Throughout 2016, we will continue to train burn specialists…

Sharon Malka

Management

Thank you, Gal, and good morning everyone. It is a pleasure to be reporting our fourth quarter and year-end financial results. We continue to fund and execute our commercial plans and clinical programs confident that our investment will drive the use and adoption of NexoBrid in Europe and advance our pipeline products in a number of important medical indications that represent significant commercial opportunities. Let me turn on to our financial results. During 2015, we shipped about 4,400 units of NexoBrid to burn centers across Europe, of which approximately two-third were part of our investment in the sampling program. The Company generated revenues of $601,000 for the full year of 2015 compared with $259,000 for the prior year. Revenues for the fourth quarter of 2015 increased to $267,000 from $124,000 in the prior year’s fourth quarter. The increase was primarily due to sales of NexoBrid associated with the mass casualty incident in Romania which were ordered in addition to the Company’s donation of humanitarian aid. As Gal noted, our efforts during the year continued to be focused on the commercialization of NexoBrid including training, market access and hands-on experience in burn centers throughout Europe. Over time and with reimbursement and formulary inclusion, we expect to drive revenues as these burn centers convert from experimental usage into commercial orders. In 2016, we will continue to invest in training and sampling programs as well as in market access initiatives that with favorable reimbursement will accelerate market adoption and will enable us to translate the positive momentum into sales. Operating expenses for 2015 were $19.3 million, which is in line with our expectation compared with $18.9 million for 2014. The increase was primarily due to an increase of $1.2 million of commercial activities associated with the European marketing infrastructure and $0.8 million due…

Gal Cohen

Management

Thank you for that review, Sharon. The progress we’ve made throughout 2015 puts us in a strong position to achieve a number of value creating milestones during 2016. These include the following: The coming readout of the top-line data from our Phase 2 study with EscharEx in the coming two weeks; continued adoption of NexoBrid in Europe; obtaining favorable reimbursement decisions for NexoBrid in Europe; ongoing enrollment of our U.S. Phase 3 study for NexoBrid; expansion of NexoBrid as an important tool in managing MCIs; and further commercialization of NexoBrid in international markets. We continue to execute our strategy and are encouraged by the enthusiastic feedback and momentum from physicians as well as from opportunities ahead in aiding governments to prepare for MCIs and the great potential of our pipeline products. And now operator, please open the call for questions.

Operator

Operator

Thank you. [Operator instruction] We will now take our first question from Matt Keeler from Credit Suisse. Please go ahead.

Matt Keeler

Analyst

I guess just to start on the Phase 2 chronic wound data; can you give us any color around what metrics you will be able to share in the press release in February?

Gal Cohen

Management

Well, the top-line data will include mainly the primary endpoints and several secondary endpoints, as well as some safety data. So obviously the primary endpoint, which is complete eschar removal; the number of applications this will require in order to reach complete eschar removal; the incidence of wounds that reached a vertical 100% or complete granulation, granulation is a kind of a tissue that you have on a wound bed of a chronic wound in order to go to the next stage of wound healing; will have the incidence of complete wound closure; will have time to wound closure. Again these are secondary endpoints, unlike many of the studies that you know because EscharEx is not a wound closure product, it’s debriding product. So, it’s not a primary endpoint, it is a safety measurement for us to show that EscharEx doesn’t have the repetitive [ph] effect on wound closer; and will also have obviously the safety measurements, so will have AEs, SAEs to the extent reported. These are the main metrics that we will be able to share following the top-line data. After we have the top-line data, we will continue the follow-up of the patients where the investigators are blinded. And this is mainly for safety. And I assume that towards the -- or during the second quarter of next year, most probably we will be able to report all the data which would be mainly quality of life, reoccurrence of wound [indiscernible] that have a more long term nature.

Matt Keeler

Analyst

Got you. Sorry go ahead.

Gal Cohen

Management

I’d say the final results will be most probably in the second quarter of this year. I was told that I said next year, so I mean this year. We are already in 2016.

Matt Keeler

Analyst

And then assuming the data looks good diabetic foot ulcers and venous leg ulcers, what’s -- can you talk us through sort of the next steps to getting into a U.S. approval and what are the implications of having EscharEx under the same IND as NexoBrid?

Gal Cohen

Management

Thank you for the question. First of all, what we did in this study mainly is to look at three different indications, diabetic foot ulcers, venous ulcers, and post-surgical complications and want to see the effects of EscharEx in each indication in order to be in a position to best design the next clinical studies, setting goals for the endpoints. We are looking at many, many endpoints in this study, mainly secondary endpoints, in order to see which endpoint makes more sense to design the most effective study going forward. Once we have these results, we will do one of two things. First of all, all the logic behind EscharEx is to take the proprietary technology and to optimize it for the treatment of chronic wounds in the U.S. We looked in the clinical and in the market studies where are these patients being treated, who is treating them, how is the compensation package or program system works in the U.S. for these patients, where are they treated and so on. So everything around EscharEx is to address these things. So, we will continue our efforts to make EscharEx even more user friendly than it is now to make it as easy as possible for healthcare provider, caregivers to administer EscharEx in the office and even maybe in the household. Once we have the results, we will approach the FDA and we will discuss with the FDA the plans going forward to see how FDA and us think that we can have the clinical development program that will bring us to the market as soon as we can. As for the FDA feedback that we do not need to submit a new IND and that we can use the same IND as NexoBrid, because it’s going to be reviewed by…

Matt Keeler

Analyst

When you say -- sorry, it’s my last question, as fast as you can, what’s sort of the best scenario I guess?

Gal Cohen

Management

I think that there are two parameters here, or I would say even three. One, one of the purposes of a Phase 2 study is to be able to power a Phase 3 study. Depending on the effects that we’ll see in the Phase 2 study, we know how many patients we need in a Phase 3 study. And this will obviously determine the length of the study. Do we need to record 400 patients or 200 patients? So, this is one parameter. The second parameter we need to discuss with FDA, can we go with one Phase 3 study, because of all the data that we already have or must we do two Phase 3 studies, which is what is usually needed for a drug to get approval to adequately randomize control studies. And the thirdly thing is whether the data that we already have would convince FDA to allow us to go to a Phase 3 study. We know what we believe, but at the end of the day the FDA decision and we’ll have to hear their thoughts and their guidance in order to know how to best move forward with our development program.

Operator

Operator

We will now take our next question from Jason Wittes from Brean Capital. Please go ahead. Your line is open.

Jason Wittes

Analyst

I wanted to ask about how you’re formulating EscharEx? And then specifically, you did a very interesting study where you polled 200 users in the U.S. And I think you mentioned about 40% of them undergo non-sharp debridement. And I’m assuming that’s at least your initial target. In our discussions with docs, there’s also quite a few patients that are basically sent home with either Santyl or some other debridement cream and just told to use it over a few week course. Can I assume that your initial formulation will be something that’s going to have to be used in a doctor’s office and eventually you’ll reformulate it for home use or what have you thought about in terms of how you might formulate EscharEx for the U.S. market?

Gal Cohen

Management

Thank you Jason for the question. This is exactly the aim behind EscharEx. If NexoBrid is a very effective product that is being used in a hospital setting, chronic wound patients in the U.S. to the best of power knowledge and best on our research are treated in offices, in nursing homes, at home by caregivers, by nurses coming to home. So, all the efforts -- or not all the efforts but much of the effort behind EscharEx is to create a presentation formulation that it will enable to use the product in a physician’s office, at home by a nurse, at home by a caregiver. And so what we’re doing, we’re investing a lot of efforts in the ease of use of the product. And as I mentioned, we will continue following the results of this study to go and further make EscharEx even more friendly or more user friendly as much as we can, because we want it to be as easy as possible for caregivers to be able to use the product, which would I believe would give the product the widest potential. So this is exactly where our efforts are and this is exactly what we’re doing. It also fits with the U.S. current reimbursement program and it fits with a patient flow and it fits with the treatment paradigms. So unlike in NexoBrid where we are changing the way burn care is being administered, in chronic wound market which is a huge market, we will make all the efforts to fit into the existing market so it will be seamless and as easy as possible for all the markets to adopt the technology.

Jason Wittes

Analyst

That’s very helpful, I mean it is from at least the initial trial indications, a much more potent product and say Santyl which is out there, should we assume that there’s going to be some additional training and pain management that is going to be required for this product or is that something that you’re looking to sort of avoid, in practice?

Gal Cohen

Management

So first of all, we always need to have some kind of guidance and factors [ph] of training for any drug but EscharEx should be quite straight product to administer, if we need to target product profile. And again unlike burns, burns are a very large wound and chronic wounds usually are not. And many chronic wounds don’t even feel pain or chronic patients having chronic wounds don’t even feel pain, and this is one of the main reasons for having a chronic wound with particularly diabetic foot ulcers and so on. And because we are using a much [Technical Difficulty] are, most probably, there is no need to do a systemic pain management like in burn patients. So even if to some patients, there would be some pain to some degree, it can always just look like [indiscernible] gel for like 20 minutes and then use the product without any discomfort. So again, as I said, we are trying to fit the current treatment paradigms in a way that it will fit a patient at home, by caregiver, by a nurse, in the office to administer the product without any discomfort or safety issues but this is exactly why we’re doing the clinical studies. This is still an investigational drug product and we have to document and do the studies to make sure that we don’t see any adverse events or anything like that.

Jason Wittes

Analyst

And you now -- you have increasingly more experience or at least the clinics, some of the clinics in Europe have increasingly more experience with NexoBrid, I’m curious in terms of they are triaging patients? And if you compare sort of the more experienced centers with less experienced centers, are those more experienced centers now treating pretty much the entire range of burn victims or is there still sort of some sort of stratification going on there.

Gal Cohen

Management

I think there is always stratification but stratification is becoming more wide if you say -- if you can say that. We have a center in Germany that treated 90 patients, 90; it means that practically every month they are treating several patients particularly on a weekly basis. We have centers in Italy. Italy’s amazing. I mean in Italy in four-five months, 14 centers which is like 80% of Italy are treating patients almost on a I would say weekly basis but particularly. And we also see differences from centers to centers. Some centers use it on hands, some centers you need some big burns because NexoBrid has many medics. If you use it on hands, you can avoid escharotomy which is particularly an emergency procedure that leaves a very nasty scar and can hurt the delicate structures in the hand. If you use it on large areas, then you can save donor sites and in large burns, to some extent there are no available donor sites. You can reduce the amount of inflammation -- the inflammatory effect of a big eschar on a patient. So we see different centers using that on different patients. And what we are trying to do is to take each center and do this peer review; the share of best practice between these care physicians. So the ones that are using it on hands will start it on face, and the ones that use it on face will start it on big burns; and the ones that use it only on second degree will see the merit and using the product on third degree burns. And I believe that this snowball is rolling, this is why we are so enthusiastic about these 90 abstracts that have been presented throughout the year, so that this target information, this knowledge, these experiences will drive additional physicians, additional centers to take a stand and move forward with technology and debride their patients with NexoBrid.

Jason Wittes

Analyst

And then last question in terms of reimbursement, can you give us a sense of which countries you may think -- you anticipate may come on line in 2016 in terms of providing full reimbursement? And secondly and related to that in your guidance for 2016, should we still assume about 75% of units or sampling units?

Gal Cohen

Management

Well for the first question, we particularly submitted the files in all the countries in Europe that require a national level reimbursement process. And these countries are the Czech Republic, the Slovak Republic, Belgium, Italy, Spain and France. In UK, we have to go through a formulary process in each hospital and we are certainly underway to do that in most of the burn centers in the UK as well. We are in different stages of the processes in different countries because each country has a bit of a different process but in general the process usually has two stages, one is that you have a scientific committee that has to give the recommendation and then if they give a positive recommendation, you have a financial committee that has to negotiate the price. According to our indications, we hope to be in a position that in the second half of 2016, we will get decisions in most of these processes, hopefully positive decisions. We have -- I believe that we have a good data; we have -- we’ve certainly demonstrated clinical benefits of the patients; we certainly demonstrated clinical and/or value -- pharmacoeconomical measurements have shown this is cost effective, but at the same time we don’t have full control because these things are being managed by processes within the governments and not always we have -- we can predict what would be the final results because of many-many parameters. But we’re hopeful that during the second half of this year, we will get decisions for most of these markets. Now, as for the free of -- or the sampling program we believe that this year hopefully about 40% to 50% of the products will be provided in this manner because as we said before if these reimbursement decisions will only get into effect -- not all of them but let’s say some of them get into effect earlier, some will get into effect in the second half of next year and until this point in time, we want to make sure that physicians are treating patients, getting more experience, rolling this snowball forward. Also there are some technical things. For example, in some countries you can get a decision and then it takes like two months until it’s published or things like that. So, this is why we believe that in ‘16, we’ll most probably sample about 40%, 50% of the year.

Operator

Operator

We will now take our next question from Raj Denhoy from Jefferies. Please go ahead. Your line is open.

Raj Denhoy

Analyst

I wonder if I could a follow-up a little bit on the last question in terms of the guidance for 2016. I know you haven’t traditionally provided top-line guidance, but is there anything you could provide for us in ‘16?

Gal Cohen

Management

As you said and thank you for the question Raj, we did not provide guidance on revenues because we believe that in this kind of a period where there are so many parameters, professionally we believe that this would not be the right approach. As I said before, if we sample about 70% in 2016 -- ‘15,and we’re going to sample about 40%, 50% in 2016, I think Sharon mentioned how many TBSA units we’ve provided in 2015. And this might give you some indication to make your own assumptions about the market. What we can give you guidance is where we do have control, and this is about cash use. So, initially in the year, we said that we’re going to use $20 million to $22 million of cash. Once we got the BARDA agreement signed, we updated our projections to $20 million and end at the end of the year we did a little bit above $19 million which is I -- because I always like to spend less than I wanted to. And we are going to do the same in ‘16. We’re going to have a guidance of about $20 million to $22 million, mainly because our clinical programs are advancing. So, that will require a little bit more capital. And we believe that we will be within this guidance during 2016 which should give enough cash to through ‘16 and mostly probably ‘17 and going forward.

Raj Denhoy

Analyst

Beyond NexoBrid, you did mention that you did expect to receive perhaps some more orders under the BARDA contract, I mean ‘16 as well as some of the funding from that. Is there anything you can provide in terms of what that could contribute in ‘16?

Gal Cohen

Management

I think that as I mentioned, the BARDA contract has two components, one is reimbursement of R&D costs. And here we believe that our cost in U.S. Phase 3 study would be reimbursed by BARDA. So, next, we should be -- this should be a big contribution to our -- or to the reduction in our R&D costs. Again our R&D costs might not be reduced so much because we are now moving into -- we go to the pediatric study, with the -- hopefully with the EscharEx study and also with our 003 program that might be in a position to go through a clinical study in late 2016. And for procurement, in order to procure the product, first of all there is commitment; there is a binding commitment in the contract for BARDA to buy product for $50 million, within the five-year frame of the contract. In order for BARDA to do that, BARDA will need to get either what we call a Emergency Use Authorization which is something that BARDA can get if they want to use a product that was not yet approved in the U.S. or once the product is approved and they have the green light to procure more. I think that according to BARDA’s timeline, most probably this -- Emergency Use Authorization would make more sense or be more credible for them in 2017. Because they said and they communicated it’s going to take them between year and a half -- or about year and half to get this thing done with the FDA. So, this is why I believe that this is the case.

Raj Denhoy

Analyst

And then just last question from me. You talked about some of the other geographies you are opening up, Latin America, Russia, going to distributors in some of these other markets. Should we expect a reimbursement timeline in those markets to be similar to what you are experiencing in Europe, or is there perhaps a faster way to get the material covered there?

Gal Cohen

Management

I think again, reimbursement is really something that has to be done on a local basis. It differs from country to country. Sometimes in some countries, it even differs from region to region within the country and sometime even within hospital to hospital. So, I believe that it really depends on the country. I think that in Mexico for example, most of the drug use is being covered by the government. In other markets, it might be different. What we have asked our distributors is to build a market access plan while they are submitting the files to build a market access plan in each one of these markets. And based on these plans, we will have a better visibility exactly where can we expect to get -- and what kind of reimbursement in different markets. I think in generally your comment is absolutely vital because you know that the opportunity in general in the emerging markets is much greater than in the U.S. or Europe because the incidence of burns is much greater. Let’s take Asia for example. 400,000 hospitalized burn patients just in India, which is anything between 4 to 10 times more than in the U.S. but at the same time, market access is not as in the U.S. But based on the marketplaces that we see from our distributors, still even in these markets, even if 10%, 15% of the population has access to market to reimbursement, the numbers are huge. Take 10% of 400,000 patients that’s 40,000 patients that’s almost like all the patients being admitted to what we call ABA burn centers in the U.S. So this is why we believe that we should pursue this international effort. We don’t think that we should reach ourselves because this market needs e local expertise that we don’t have. We also don’t have the span to be all over, so we focus on the U.S. and Europe but we are very fortunate to be -- find partners in particularly now almost all Latin America, in Asia Pacific and in Russia. And we are discussing with company’s possibilities to expand this reach to I would say important markets in the Far East.

Raj Denhoy

Analyst

And those arrangements that will be traditional sort of distributor arrangements where either they -- well perhaps if you could describe what those will look like; will they be buying the material firm you or will you be -- how is that going to work practically?

Gal Cohen

Management

I think that they are going to buy the products from us. And taking into account that we are fully integrated company that does the development, does the manufacturing and has all the marketing and medical corporate support, we would see a significant portion of the revenue of the product within MediWound. And we -- their responsibility would be to submit the file, get it approved, get market reimbursement, and market the product, while we are manufacturing and supplying the product and supporting them on a regulatory, medical and marketing basis.

Operator

Operator

We will now take our next question from Akiva Felt from Oppenheimer. Please go ahead.

Akiva Felt

Analyst

Sharon might hit at this. But the quarterly revenue growth Q4 over Q3, how much of that was patient growth versus your improvement in reimbursement or other factors?

Sharon Malka

Management

Most of the increase or the majority of the increase was the increase in number of patients treated, not as a result of reimbursement.

Akiva Felt

Analyst

And Gal, for the U.S. approval of NexoBrid on the acute phase results, is your expectation that this will be a formal accelerated approval pathway or just a standard approval filing?

Gal Cohen

Management

Thank you for the question. Maybe one about previous question and then I’ll address your second question. I think that there are three metrics that we can expand on in order to increase the use and later on the revenues of NexoBrid. One is more centers; two is larger patients; and three is more patients. So, on all these metrics we can particularly expand use of NexoBrid. As for the second question, we don’t yet have an official message from the FDA of what we call priority review or breakthrough technology or accelerated review. Our strategy is based on medical merit, I mean once we have the acute data of the Phase 3 study, which is particularly all the data except for maybe cosmesis and function and quality of life. If all the -- subject to, so if all the acute data is good and there are no safety concerns, logically there isn’t a -- the concern of having a long-term -- the serious [ph] effect is much lessened. Add to that the fact that we already have a long-term study in Europe in 89 patients showing that the long-term cosmesis and function of NexoBrid was at least as good if not better than the Standard-Of-Care. So subject to having all this data as well as a safety data at this stage, which is particularly I would say 90% of the data, we hope to be in a position to convince the FDA to allow us to submit a file and to supplement the long-term data thereafter. Because just look at the data, you get the last patient in, you treat him, you get to wound closure, you wait for three months for what we call -- which is based on the guideline, a confirmation of wound closure and then you prepare a file and you submit the file. By the time you submit the file, particularly you are few months away from 12 months long-term data. So by the time that FDA validates the file and starts to review the file, we can be in a position that we can soon supplement the 12-month data. So, we believe that this makes sense if the data will be good at the acute stage. But yes, this is an FDA decision and we will stick whatever the FDA can guide us about that.

Operator

Operator

We will now take our next question from Bruce Nudell from SunTrust. Please go ahead. Your line is open.

Bruce Nudell

Analyst

I guess, I just had a question about what the market research has revealed about the choreography and the reimbursement in the setting of the treatment of chronic wound. So, like 1% is done by scraping, how much is informatics? And could you say that -- what are the reimbursement situations for the provider those circumstances? And what does that mean for the opportunity and/or challenges for NexoBrid in a chronic wound setting, I guess speaking to the United States because I guess that’s where you’ve done your market research? Thanks so much.

Gal Cohen

Management

So thanks Bruce for joining and for the question. From what we learned from the study, it seems as follows: First of all, as you know chronic wounds are mainly treated at outpatient setting in the hospital, offices, outside an outpatient setting in the hospital, clinics, in nursing homes, in longer rehabilitation centers and even in the patient’s home by nurses and caregivers. The patients are debrided. I would say more than half of the patients are debrided by what we called sharp debridement. And bulk -- I would say fifth of them are debrided by enzymes and a fifth of them are debrided by other non-surgical means like honey dressings, idole gels, you name it, like many, many, many, technologies. So the first obvious market would be to go to the other non-surgical approaches which is about 40%, 50% of all the use of debridement in the U.S., again a huge, huge opportunity already by itself. The market study also shows that many of the patients that are going to sharp debridement are still going alongside with a non-surgical debridement option. Because again I think it’s -- in chronic wounds, it’s not like a burn patient that you have to excise all the burn and all the eschar, you are concerned about scars, you are infections that will kill the patients. So in chronic wounds, physicians are much more cautious about -- these patients in general are not healthy patients, they’re usually elderly patients, they don’t heal well. So, they’re very cautious about what you can remove with the sharp instrument. Because of that we believe there is a great potential for all the patients that are treated non-surgically or non-sharp debridement and in addition to that opportunity in the ones that do even go through sharp debridement. Now in terms of reimbursement, so physicians are being compensated mainly for two things. One, either for the sharp debridement or for office visits. So, we believe that one thing that one can look at is there is an enzyme in the U.S., it is reimbursed; it has -- you just have a prescription, the physician is being reimbursed for the visit, the patient buys the prescription at home, he has a co-pay or doesn’t have a co-pay depending on his program and he uses the product, it’s been supplied [ph] by two times a week in the clinic or somebody at home can do that for him, either a nurse or a caregiver. Here we are thinking of using the same system. And just once we get NexoBrid -- sorry if and when EscharEx is being approved in the U.S., hopefully it can fit into a similar pattern and life would be as usual. Maybe instead of using the product for six or eight weeks, it will possibly do it in a week, if the data supports this level of efficacy.

Bruce Nudell

Analyst

Perfect. And then based on your market experience in Europe so far, I know earlier on you felt that the vast majority of hospitalized burn patients are likely ultimately to be treated with NexoBrid, so 70% to 80% of hospitalized burn patients. Now that you have had experience in kind of running to the operational complexities of the treatment burn patients inclusive of the -- perhaps pecuniary incentives on the part of some surgeons, when do you think that peak adoption might be in the setting of the hospitalized burns?

Gal Cohen

Management

Okay. You are asking about NexoBrid?

Bruce Nudell

Analyst

NexoBrid of course. Yes.

Gal Cohen

Management

Okay. So, can you please repeat the last question? I wasn’t sure I fully understood the question.

Bruce Nudell

Analyst

Just early on we saw that the vast majority of hospitalized burn patients would be ultimately treated with NexoBrid as any alternative to the dermatome. And now that you’ve kind of had the experience and see the all gross incentives that various clinicians might have, what do you think that peak penetrate may ultimately would be?

Gal Cohen

Management

I think that eventually at the end of the day it’s going to be the standard of care because I don’t see any reason. As I said at the end of the day there are two kinds of patients, the one that you take to the operating room and the one that you don’t. So with the ones that you do take to the operating room, why take a patient to the operating room, excising on general anesthesia, lose a lot of blood, practically remove varieties that you want to preserve; if you can’t remove the eschar in four hours, then the patient’s dead. And for the ones that you do not excise, why put synergy on a patient for two weeks, if you can get their eschar off in four hours. Having said that I think that the best way to go there will not happen overnight, because we particularly have to deal with three circles, I say. First of all is the physician. The physician has to feel comfortable with the treatment. He needs to know how to apply it, how to assess it, what to do after. And taking a physician from a comfort zone to a new thing and you have to give him the comfort that he knows what to do and to get good results. And this is something that starts with early adopters, expands to the other physicians, and eventually will go to I think most of the treating physicians. And different physicians, as I mentioned start differently; some start with second degree burns, some start with third degree burns, some start with hands, some starts with backs, some start with faces. But eventually when all these physicians will hear the appeal and will understand that most of the third degree burns once…

Bruce Nudell

Analyst

And just very quickly what percent of hospitalized patients in your sense now that you’re in the hospitals are actually going into operating room to get debrided?

Gal Cohen

Management

What is the percent of patients, in general you mean?

Bruce Nudell

Analyst

Of hospital patients who are in hospitals or actually going to the operating room to get debrided?

Gal Cohen

Management

If I understand correctly your question in the standard of care what we saw in our clinical studies is about 70% of the patients are going to be surgically excised.

Operator

Operator

As there are no further questions in the queue at this time, that will conclude today’s question-and-answer session. I would now like to turn the call back to our host Mr. Cohen for any additional or closing remarks.

Gal Cohen

Management

Thank you. Thank you for your questions and for your continued interest in MediWound. We look forward to updating you again when we report our first quarter 2016 results in about three months. Have a great day and keep safe with all the snow out there. Bye-bye.

Operator

Operator

That will conclude today’s conference call. Thank you for your participation. Ladies and gentlemen, you may now disconnect.