Mediwound Ltd (MDWD) 2014 Q2 法說會逐字稿

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  • Operator

  • Good day, ladies and gentlemen, and welcome to the MediWound Second Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.

  • (Operator Instructions).

  • As a reminder today's conference is being recorded.

  • I would like to introduce your host for today's conference call Ms. Anne Marie Fields with LHA. You may begin, ma'am.

  • Anne Marie Fields - SVP

  • Thank you. 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, President and Chief Executive Officer and Sharon Malka, Chief Financial and Operations Officer.

  • Earlier this morning, MediWound announced financial results for the three and six months ended June 30th, 2014. If you have not released this new 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 [Caroline Keren].

  • 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 F-1 and 6-K which identifies 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 July 31st, 2014. MediWound undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

  • So with that said, I would like to turn the call over to Gal Cohen, Gal?

  • Gal Cohen - CEO

  • Thank you very much, Anne Marie. Good morning, everyone. Thank you all for your interest in MediWound and for participating in our first quarterly conference call as a publicly traded company. We are pleased to share with you the progress that we have made throughout the second quarter in our commercial operations, our research and development and our manufacturing.

  • As planned, we are moving along the marketing axis of awareness, interest, views and adoption for next of breed our innovative pharmaceutical products. We are actively working on increasing awareness and educating burn specialist on the benefits of NexoBrid in treating their severe burned patients.

  • In the last six months, we have been participating in every key regional and national medical conferences for burn specialists where we are presenting NexoBrid and highlighting its benefits involving the scientific and clinical session.

  • In line with our strategy, in January, we are participating in the [Dove] conference for the German-speaking countries, Germany, Austria and Switzerland. In May, we participated in the Nordic Burn Meeting in Sweden and in July, in the U.K., European Society of Plastic, Reconstructive and Aesthetic Surgery Conference.

  • These conferences include scientific programs and commercial workshops highlighting NexoBrid's effective, fast and selective [idiomatic] (inaudible) capabilities in the treatment of severe burns. We also plan to attend the Burn and Wound Healing Conference in Poland in September, the International Society of Burn Injuries Conference in October and the Italian Burn Society Conference in Italy in November.

  • Looking ahead, we intend to take a dominant provision in every major regional and national European burn conference in the coming year. We will amplify our support and collaboration with the burn community by playing a major role in European conferences in 2015 as well.

  • [Visibility] at these conferences creates considerable awareness, interest and if I may say also enthusiasm for NexoBrid. In addition, we are generating more data to share with the burn community through our publication plan to promote an evidence-based approach to burn care.

  • As many of you already know, we initially launched NexoBrid in Germany just before Christmas. Our primary calling points are the burn centers and the burn units where we have now completed the training of the [meeting] clinical teams who treat patients with severe burns.

  • We are pleased with the progress of our team and with the introductory phase of the launch. We expect to build on this foundation to expand the use of NexoBrid from an innovative treatment to actually standard of care. The introduction of a new treatment paradigm typically is a process and until it's fully integrated into the physician's day-to-day practice.

  • We are managing now this process in the following way. We begin by hosting a scientific [check-in] for the burn team in every burn center in Germany and thereafter in the rest of Europe. This includes key opinion leaders who share their experience, who openly dialog with the team and address the team's questions.

  • Thereafter, we provide the burn center with NexoBrid so that they can have hands-on experience and learn more about the product in real-life settings. The center typically starts with one or two milds to small burn and follow them for about a month until they are healed. At that point in time, they add more and more patients and gradually overtime, the treatment is incorporated by more and more [side] champions.

  • It has proven itself to be successful as the center of our learning and integrating the technology into their day-to-day routine. And we believe that it will take time, but with time, we are confident that we'll be in a position where NexoBrid is becoming the future standard of care.

  • In Germany consistent with the processes I've just described, we already have early adopters who are currently reordering NexoBrid. Others are trying out the product for the first time and we hope to hear from them soon with order as well.

  • Obviously as usual there is a third group of what we call later adopters who are closely watching their peers and we anticipate that they will in turn come and start to order NexoBrid as well. Our approach is focused. It is [statute] process and we are seeing a strong response from the market. In fact some KOLs have issued their own press releases announcing their enthusiasm from use of NexoBrid with subsequent local media coverage.

  • In the second quarter, we also make significant progress toward expanding into additional new countries. As reported, we have completed the recruitment of our commercial team in Germany, in Austria and we hired seven country business managers who are now leading our commercial efforts in the UK, in France, in Italy, in Spain, in Central and Eastern Europe, in Scandinavia and in Benelux.

  • These business managers are all experienced sales and marketing executives who have successfully led such activities in the past in their local market with other innovative products. Overall, we have brought into the company more than 130 years of local marketing and sales experience by joining these executives in our teams.

  • Our business managers are currently actively recruiting local sales and marketing teams and fine tuning and executing their local market access and launch strategies.

  • We oversee MediWound's commercialization efforts in Europe, I am happy to say that we have recently promoted Carsten Henke to be the Chief Commercial Officer in Europe in line with our corporate leadership strategy.

  • We remain on track to have our commercial team in place by the end of the year to support our expanded launch into the other European countries. As I also mentioned, we are now finalizing and executing our market access strategies on a country-by-country basis.

  • In most countries where we can have direct access to the hospital without the prerequisite of a national level reimbursement like in Germany for example, we are initiating sales by going directly to the burn centers without or reducing our budget index tool to demonstrate NexoBrid cost effectiveness within the current hospital setting.

  • In countries where the national level reimbursement is a prerequisite for example France, we are about to submit the health technology assessment file to obtain such national level reimbursement. We are confident that we will be able to demonstrate both the clinical and the cost-effective benefits of NexoBrid in treating severe burn patients.

  • In addition to the progress that we have made in Europe, we've made a great progress also in global commercialization of NexoBrid. We are very pleased to report that we have now established a marketing and distribution presence for NexoBrid in addition to Europe in all [between lane] international geographies.

  • We signed a distribution agreement for NexoBrid in Argentina, in Russia and in South Korea and in addition, with the recent marketing approval for NexoBrid from the Israel Ministry of Health, we are ready to launch here with our local sales team.

  • We are currently in varying stages of engagement with many, many local distributors in the three regions of our focus. Such distributors have local market expertise in promoting innovative products to medical specialist in the hospital setting with the goal in mind to making NexoBrid available to help severe burn victims all over the world.

  • Let's now move to the progress that we've made in the R&D plan. First of all really enforce our leadership team with the addition of Dr. Ety Klinger as our Chief R&D Officer. Dr. Klinger is an accomplished executive with expensive R&D experience. For over 17 years, Dr. Klinger served in numerous leadership positions at Teva Global Innovative R&D division. Dr. Klinger was a key member of the Copaxone development team. So I have a first-hand knowledge of her exceptional ability to lead and execute R&D programs.

  • With regards to our development program for NexoBrid, we continue our efforts to bring NexoBrid to the U.S. We are pleased to report that we have submitted a clinical protocol to the Institutional Review Board. We have completed all the preparations for the study and we will start the patient recruitment as soon as we get the R&D approval.

  • We have also submitted the study protocol to the IRBs of the European authorities or the European side of the NexoBrid pediatric study in burn patients.

  • As I mentioned here again, we have completed all the preparations for this study as well and we will start patient recruitment once we have the IRB approval.

  • This pediatric study if I may say is very important to us as you know that surgically treating children is even more demanding than adults. Being able to spare these children from surgery or even reduce the number or extent of surgical excisions and autografting is important for achieving more favorable outcomes in this important population.

  • In addition to our R&D effort with NexoBrid, we continue as planned with our second product program or EscharEx for the treatment of chronic and other hard to heal wounds. We initiated our second Phase 2 trial of EscharEx for the debriding [values] wounded etiologies such as diabetic foot ulcers, venous ulcers and other post-surgical trauma and hard to heal wounds.

  • As you know, EscharEx is based on the same technology as NexoBrid, so we believe its development program is significantly derisked. Our vast clinical experience with NexoBrid provides us with a wealth of clinical data, as well as with preclinical, toxicology, manufacturing control data. This is an important risk-reducing factor that allows us to focus our efforts on the Phase 2 and hopefully, consequently, on the Phase 3 clinical development of EscharEx in order to bring EscharEx to the market.

  • EscharEx addresses an under-served medical need for an effective scar removal in chronic wounds. As you know, chronic wound is a multi-billion dollar fast-growing market and it's a huge opportunity for us due to the aging population, diabetes and obesity. We are very happy to report that we have started to recruit patients for this study. And we anticipate having top line data for this study in the second half of 2015.

  • In addition to that, as a fully-integrated company, manufacturing is a core competency and is critical for our commercial success. So we are very pleased to report the successful completion of a good manufacturing practice, the GMP audit of our facility by the Ministry of Health. The audit was part of the routine evaluation of our manufacturing facility, and the audit reconfirms our compliance with cGMP for three years. This audit fulfills the requirement for the European Union as well. The focus on high standard and quality is very important to us in everything that we do. And we see this audit as validating our efforts.

  • Now, I will turn the call over to Sharon Malka, our CFO for the review of our finances. Sharon, please go ahead.

  • Sharon Malka - CFO and COO

  • Thank you, Gal, and good morning everyone. It is a pleasure to be reporting our second quarter financial results. MediWound has met significant progress throughout the first six months of 2014. Our U.S. IPO provided us with growth capital to expand our marketing infrastructure in Europe and execute our planned clinical development.

  • Let me turn now to our financial results. Revenue for the first six months of 2014 were approximately $100,000, which reflects initial sales of NexoBrid in Germany as we are still early in the launch phase. As Gal noted, our efforts are primarily focused on transitioning from awareness and interest into use of -- and adoption in burn centers throughout Germany.

  • Our operating expenses for the second quarter of 2014 were $4.5 million, compared with $1.7 million in the same period of 2013. The increase was primarily due to $1.4 million of commercial activities associated with building our European marketing infrastructure and a $1 million increase in a noncash share based compensation expenses. Operating expenses for the first half of 2014 were $8.8 million, compared with $3.1 million in the first half of 2013. And include $2.5 million of commercial activities and about $2.2 million increase in non-cash share based compensation expenses.

  • For the second quarter of 2014, we posted a net loss of $6 million or $0.28 per share. Net loss for the first six months ended June 30, 2014 was about $6.8 million or $0.37 per share. In the first quarter of 2014, we recognized one-time noncash financial income of about $4 million related to the reevaluation of financial derivative.

  • Adjusted EBITDA for the second quarter of 2014 was a loss of $3.9 million, compared with a loss of $1.5 million for the same quarter last year. Adjusted EBITDA for the first six months of 2014 was a loss of $6.6 million compared with a loss of $2.8 million for the same period last year. As of June 30, 2014, we had $73.6 million in cash and bank deposit. And our working capital was about $74.4 million.

  • We have invested in key areas that we are confident will provide us with a platform from which to drive revenue and build a sustainable biotechnology company. We used about $7.6 million in cash during the first six months of 2014 to fund ongoing operating activities.

  • As we have discussed, we plan to continue to invest in our marketing infrastructure in Europe and in the scale up of our manufacturing capabilities. We will also fund further clinical development of NexoBrid and EscharEx, and we'll support efforts to obtain regulatory approvals worldwide. As a result, we expect cash spend will increase. We believe that our existing cash balance will be sufficient to fund our work plan and operation to a meaningful revenue buildup and break even.

  • Now, I will turn the call back to Gal. Gal, please.

  • Gal Cohen - CEO

  • Thank you, Sharon. The first half of 2014 was a transformational time for MediWound as we have launched NexoBrid in Germany and completed our U.S. IPO. With a capital to execute our plan now in hand, we have multiple activities underway to build our commercial foundation in Europe, and to advance our clinical development programs.

  • We are confident that our investments in additional clinical studies and our collaborative efforts with burn centers will drive the use and adoption of NexoBrid. We look forward to continuing to execute our strategic plans and to sharing with you our ongoing progress. Thank you for your time today.

  • And now, operator, please open the call for questions.

  • Operator

  • (Operator Instructions) Our first question comes from Bruce Nudell with Credit Suisse.

  • Unidentified Audience Member

  • It's [Matt] on for Bruce. Can you hear me okay?

  • Gal Cohen - CEO

  • Yes.

  • Unidentified Audience Member

  • Thanks. I have a couple of questions. The first is on reimbursement adequacy in Germany today and whether or not that's a headwind to adoption. And also, about timing for a potential [NUB] add-on and what that could mean for you.

  • Gal Cohen - CEO

  • If I understand you correctly, what we see now in the situation in Germany is that we do not have to have what is called a national level reimbursement. We are working with our budget impact tool. We are going center by center, and we are demonstrating to the physicians as well as to the administrators that by using NexoBrid they are actually improving their financial status because NexoBrid is cost-effective.

  • Once more information will be gathered in the German sites and we have already started to discuss that with some of the key opinion leaders in Germany, including the head of the German Burn Association, which issued a press release if you saw a couple of months ago. Once more information will be gathered, we will be trying to obtain a specific code for NexoBrid in rheumatic surgery. But currently, this is not a limiting factor in our advancement.

  • Unidentified Audience Member

  • Okay. And then in your press release you said you've completed training of all the German major burn centers. Can you tell us when that training completed? And now that they are trained, are you kind of -- is your commercial infrastructure in place as you could sell in all those centers today?

  • Gal Cohen - CEO

  • Yes, thank you for the question. We have finished the initial training of all the other burn centers in Germany. And what we see, the typical picture of any introduction of a new technology into a market. We see several centers that are what we call early adopters. These centers have already hands-on confidence with using the product, and they are now reordering the product when they need.

  • We see a third of the centers or some of the centers going through the first stages when they are treating the patients usually waiting for approximately a month until they see that the patient is completely healed. Although the debridement stage, obviously, is over after a couple of hours, they want to see how the patient's [cause] is advancing. Then they go and treat another patient.

  • Usually they start with a smaller patient or a more mild patient because they want to get more confident. And once this happens then the process repeats itself with additional champion remedial centers, because every center has more than one physician. So over several months this process is being -- going on. And eventually these centers go from a stage of, I would say, investigating the technology or trying the technology to become a user of the technology.

  • And then we see a certain amount of centers that are watching their colleagues as they use the technology. They want to hear their impressions before they are more willing to start and implement it themselves. And in any market that you enter like we did with other products, you always have the early adopters, the general physicians, and the late adopters, I would say. So this is a natural course of introducing a technology into any field.

  • Unidentified Audience Member

  • Okay. And so you do have -- you have enough feet on the street now to sell into all these centers that you've trained.

  • Gal Cohen - CEO

  • Yes, we have -- all the commercial infrastructure in Germany is up and running. So we have the key account managers, we have the medical directors, we have the marketing force, everybody's working now.

  • Unidentified Audience Member

  • Okay, perfect. Thanks for taking the questions.

  • Gal Cohen - CEO

  • Thank you.

  • Operator

  • Our next question comes from Raj Denhoy with Jefferies.

  • Raj Denhoy - Analyst

  • I wonder if I could ask about the U.S. timing. You know it's not that much of a delay, but the start of the trial here in the U.S. is maybe three, four months behind schedule. And I'm curious if you have any insight into that? Is there anything we should be thinking about in that delay.

  • Gal Cohen - CEO

  • Well, we don't see that really as a delay. We have said that we will complete and we'll initiate the study by -- in the first half of 2014. And we have, as planned, completed all the preparations for the U.S. study on time.

  • We have the CRO in place. We have trained all the centers. We have done investigator meetings -- a very successful one in Chicago on April. We have a central lab. We have a depot. We have the clinical supplies ready to be used. And we have submitted the protocol to the IRB.

  • Now, we are just waiting for the IRB to approve the protocol, which is obviously a prerequisite to initiate a study. This process usually takes a couple of months or so, but obviously we don't have direct control over the timelines and processes within the IRB being an independent review board. So we are ready with everything. As soon as the IRB gives us the approval, we will initiate the study.

  • Raj Denhoy - Analyst

  • Okay. And then maybe you could just remind us, once the trial does begin your expectations for how long it will take to enroll and if there's any possibility. And perhaps a shorter follow-up or whether you're constrained by what the FDA is going to need in terms of how long that trial will take.

  • Gal Cohen - CEO

  • Well, as we said, we prefer to be more conservative in terms of recruitment. So our plans suggests a two-year recruitment period followed by a 12-month follow-up for the cosmetics and function, which is one of the primary endpoints, because it takes at least 12 months for the burn to mature and for the scar to be stabilized so that we can actually assess the quality of the scar. And we know that the information that we gather is more or less final. So we are looking at three years overall, or two years of recruitment and then 12 months of follow-up.

  • At that point in time, we are going to do an interim analysis. If we are able to replicate the results that we have in Europe, because we have to remember that this endpoint, the endpoint of cosmetics and function is a non-inferiority endpoint.

  • So all we need to prove is that we are not worst than standard-of-care. In Europe, our result was actually a bit better than standard-of-care. So if we are able to replicate the European results, we'll be able to stop the study at the interim analysis based on predesigned stopping rules and go for a submission.

  • If at this point in time we have not yet been able to confirm that, we have the option to continue the follow-up for another 12 months and thereafter to have the final results. So this is the overall timeline of the study. Okay? We don't think that we will be able to shorten the follow-up period because we just have to wait that. We prefer to anticipate a two-year recruitment. Although I can assure you that we will do everything in our power to accelerate this process.

  • Raj Denhoy - Analyst

  • Okay. That's helpful. And maybe I could ask a bit about the Germany experience, it's very helpful to hear how the adoption takes place there. But as you've now been commercialized there for several months; what have you learned in terms of what is [gating] that adoption? I mean, it doesn't sound like lack of formal reimbursement is a hurdle. But are there other things that you've learned that are perhaps slowing or accelerating the adoption of next (inaudible) in that market?

  • Gal Cohen - CEO

  • Thank you for the question. I would say that one of the main things that need to happen is just assimilation of the technology into routine use in the center. The centers are used to working in certain for many, many, many years. So when a burn patient comes in the nurse knows what she needs to do, the physician knows what he needs to do, the pharmacists knows what he needs to do. They have a routine, they have an SOP.

  • Now, they need to adopt. They need to change this SOP. In order to change this SOP they first have to have some hands-on experience to see how it works in their hands. And this process of changing the workflow if you may is what is taking more time.

  • In centers where it's not -- where it's faster in the early adopters where, you know, they run faster on the learning curve this happens faster. And in other centers, it takes a bit more time. And again, there are always people just say, "We've been using [Fusion] for 20 years before we change our ways, we want to see our peers do that and see how it works for them."

  • So we are just running on this learning curve and we think that the [new] form interest to I would say a confidence is really a function of number of patients. The more patients they treat, the more confidence they have, the more easier for them to adopt it into their routine practices.

  • Raj Denhoy - Analyst

  • Okay. And then just lastly and I realize revenues are still relatively de minimis as you described them coming out of Europe so far. Given that you've now signed up some distributors the German market is primed now; when do you think we will start to see the revenues build it at a faster clip? And I guess, buried in that is there any sort of guidance you're willing to provide in terms of revenues this year and even next?

  • Gal Cohen - CEO

  • Sharon, would you like to take this question?

  • Sharon Malka - CFO and COO

  • Yes. Thank you. Hi, Raj. Actually, we are still early in the launch of the NexoBrid in Europe. And we will not be able to provide financial guidance at this time. And we believe that moving forward as we gain greater visibility [into this], our commercial progress we may revisit this decision. We've done two launches and the predictability of [first] is not clear in such a phase.

  • Gal Cohen - CEO

  • Okay. I would like to add that as Sharon mentioned, we are now planning to launch in the additional European markets every -- in every quarter in several countries. And as we communicated from the beginning, we believe just based on the clinical and other properties of NexoBrid, we will become standard-of-care. But we are realistic to think that this is the process that will most probably take over about five years as usually done innovative products and in orphan drugs.

  • So we expect the first couple of years to be a stage where we introduce the technology, the centers adopt the technology, they run on -- (inaudible) into their processes and the more time and with more and more time, this will also be reflected in the, what you referred to as revenues. But we should expect that in the short term, we are not going to be standard of care in a year or two. It takes a bit of time.

  • Raj Denhoy - Analyst

  • Okay. That's helpful. Thank you.

  • Operator

  • Our next question comes from Akiva Felt with Oppenheimer.

  • Akiva Felt - Analyst

  • Sharon, thanks for taking the questions. Most of my questions have been asked just looking for perhaps some additional color out of Germany. I mean was there anything about your initial assumptions on the marketing message that you may want to tweak or any feedback from the physicians that you haven't been expecting?

  • And then second question; could you maybe outline what the total market opportunity just in Germany alone would be from a dollar amount? Thank you.

  • Gal Cohen - CEO

  • Thank you. So I will address the first question and Sharon will address the second question. In terms of the first question, first of all, we learn all the time; we are working with our customers, we learn from our customers, and we try to adopt our ways to fit more and more to the -- a customer's needs.

  • I won't say that we learned anything strategically, but on in practical manner, I will say creating more user friendly tools for them to ease the adoption curve like checklist and things like that. They come back to the center after they treat four or five patients. Our experts are sitting with them, discussing with them the cases that they have done, trying to see where they had difficulties, where they didn't have difficulties. Most of the times obviously the difficulties are not at the stage of debridement, it's post debridement.

  • We are now working to see how we can work more with also the nurses; how can we leverage or work more with the patient organizations. So we have many, many work streams going on. We are also improving our training sessions by learning the feedback on the physicians, seeing what they understand better, what takes another round of explanation and [protect] -- or improving our training material all the time.

  • So this is a process where we learned from the market and we adapt ourselves. But I can't say that we have learned anything strategically that surprises us. It's just basically account management. You have to know your customer. One customer is not interested in science, one is more interested in publication, one is more interested in being in the advisory board and so on. So you have to work with your customers and have customer's [responsiveness].

  • Regarding the second question, Sharon, would you like to address the second question?

  • Sharon Malka - CFO and COO

  • Thanks. Hi, Akiva. Regarding to the German market potential; as you remember we talked about 80,000 to 100,000 patients, hospitalized patients throughout the E.U. As you note the German population, if you start with the German population, so Germany will present about 20% or 60% of this E.U. market.

  • And we believe that in Germany, there is about 16,000 patient overall hospitalized patients with severe burns. Out of them about 12,000 are adults which is the current target market of MediWound and NexoBrid.

  • The average price or the net price for 1% TBSA is about $450 into a substantially crossover in the pricing study that we conduct -- a few pricing studies that we conducted in German and throughout the E.U. countries. And as you know the average patient is about 10% TBSA. So you have the math.

  • Akiva Felt - Analyst

  • Okay. Thank you. That's helpful. And congratulations on all the progress.

  • Sharon Malka - CFO and COO

  • Thank you.

  • Gal Cohen - CEO

  • Thank you. Maybe just another color than I can share, I mean, I think that when we go to conferences, when we meet with physicians, we see a lot of enthusiasm, a lot of interest from the physicians. We rarely see somebody that is not interested. It doesn't want to stop and try. It doesn't want to stop and use it.

  • We have the men on ground in Germany practically, I mean, at the level of the key accounts the beginning of the second quarter so practically they are doing their legwork for about a quarter now. And I'm sure that once we continue these efforts we will see more and more move from a wellness to interest, from interest to use, from use to advocacy.

  • Operator

  • Our next question is a follow-up question from Bruce Nudell with Credit Suisse.

  • Bruce Nudell - Analyst

  • A couple of follow-ups. I was wondering if you could give us any color on what price you're realizing in Germany.

  • Gal Cohen - CEO

  • Thank you for the question. I think that Sharon refer to that. As you know in Europe, some countries in terms of market access have a -- have what is called "The reference counties" okay. For example; in some of the Central Eastern countries you have to give price references on three countries for the government to determine the price in that country.

  • So I'm not sure that it will be wise to publish exactly the price that we are requesting. What I can tell you is that, as Sharon mentioned, we of course substantiated the price points throughout Europe in several exercises. We had [UBC] in the U.K. during that several years ago. We had solutions for a health adjust (inaudible) I'd say like last year or during the last year in Germany.

  • And now we have repeated the same exercise with IMS in all the major countries in Europe going from physicians to administrators, to payers, to health economic evaluations, what is called the, "HTA model", to -- and based on all of these -- and also for the budget impact tools that is looking at that from the hospital standpoint.

  • All in all, I think that all of this information cost substantiated a price of at least a EUR400 per 1% total body surface area. Having said that, the price itself in each specific place is something that I'm not sure that we want to communicate at this point in time.

  • Bruce Nudell - Analyst

  • Okay. That's very helpful. Thanks. And just one follow-up; could you give us a little more color on you talked about how the initial trialing phase works with new users but are you providing products free of charge for the first couple of cases and sort of how many cases before you recognized revenue from new user?

  • Gal Cohen - CEO

  • Yes. Well, again, it depends on the center. It depends how many physicians there are in the center. How many physicians will need to try the product? It depends on the learning curve of the center, some centers get it very quickly and they become what we call now "Centers of Excellence," that we later on project their knowledge to additional centers within the country. And some centers take more time.

  • So this is like a local tactic, I would say, even a key account manager level of tactics to see whether a center will need to treat one patient, two patients, five patients. I don't think that we put a lot of emphasis that -- on that because as I said before, I don't think that whether we -- and the most important thing for us now is the use and adoption rather than whether they buy another -- a much more cheaper or not. And this is transition period. So once this is up and running all the products will be sold, so (inaudible) --

  • Bruce Nudell - Analyst

  • Okay. Thank you. Sorry. Then just one follow-up and I'll drop. Can you remind us, how long is your German selling infrastructure been in place?

  • Gal Cohen - CEO

  • Yes. Well, at the level of the key account managers, the ones that [I've been] visiting the centers frequently, they have been recruited on April. And at the beginning obviously we have trained them, I would say through April. And since then, they have been visiting the burn centers for a couple months now maybe three months.

  • Obviously as you all know, Europe during July and August [dooms] down to this. But we are continuing our efforts and we are meeting with our customers every day and every week of the day -- everyday of the week.

  • Bruce Nudell - Analyst

  • Okay. Thank you so much.

  • Operator

  • I'm not showing any further questions at this time. I would like to turn the conference back over to Gal Cohen for closing remarks.

  • Gal Cohen - CEO

  • Thank you very much. I would like to thank you for your questions and for your interest in MediWound. We look forward to and updating you again when we report our third quarter results in late October or in early November. Have a good day. And thank you very, very much for participating in the call.

  • Operator

  • Ladies and gentlemen, that concludes today's presentation. You may now disconnect and have a wonderful day.