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MediWound Ltd. (MDWD)

Q3 2014 Earnings Call· Wed, Nov 5, 2014

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Transcript

Operator

Operator

Good ladies and gentlemen and welcome to the MediWound 3Q 2014 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 now like to turn the conference over to Anne Marie Fields from LHA. Ma'am you may begin.

Anne Marie Fields

Management

Thank you good afternoon. 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 Officer. Following the close of the stock market today MediWound announced financial result for the three and nine months ended September 30, 2014. If you have not received this new release 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 began 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 filing to the Securities and Exchange Commission including without limitation the company’s Form-20S and 6-K which identifies which identifies specific factors that may cause actual result or event to differ materially from those described in the forward looking statements. Furthermore the content of this conference call contains time to time sort of information that is accurate only as of the date of the live broadcast November 5, 2014. MediWound undertakes no obligations to revised or update any statement to reflect event 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

Management

Thank you Anne Marie. Good afternoon to all listeners in the U.S. and good evening to those joining us on [indiscernible]. Thank you all for your interest in MediWound and for participating in today’s call. We have made a considerable progress throughout the third quarter as we continue to execute our strategy as planned. In particular, we made a lot of headway with our commercial and clinical progress which I will highlight for you in today’s call. First, let me review the company’s ongoing commercial progress with our lead product NexoBrid in New York. As many of you know we introduced NexoBrid in Germany LEDCM with significant launched efforts beginning in the second quarter when we hired our own ground [indiscernible]. Our primary calling points are the burn centers and the burn unit in Germany when we have completed a training of delivering clinical team and treat patients with severe burns. As we have noted before the introduction of a new treatment paradigm takes time to integrate into the hospital long standing working practices. We believe that NexoBrid will become the standoff cure however as any new therapy introduction there are few necessary steps to market adoption. These are awareness and interest; use an advocacy [ph]. Let me review our initiative and progress in each of these three steps. With regards to awareness we made a significant progress developing awareness and educating burn specialist and the clinical merit of NexoBrid through ends and pull with the way severe burns are treated. In addition to calling on physicians at the major burn centers, we have been active at the key regional and national medical conference for burn specialist well showcased NexoBrid and highlighted its benefit in both the scientific and clinical session. For example, we significantly end the visibility of NexoBrid…

Sharon Malka

Management

Thank you Gal. Good afternoon everyone it is pleasure to be reporting our third quarter financial result. We continue to fund and execute our commercial plans and our clinical program being confident that our investments will drive the use and adoption of NexoBrid and advance our pipeline product. Let me now turn to our financial result. Revenue for the first nine months of 2014 was approximately 135,000 reflecting into factory sales of NexoBrid in Germany as we are still early in the launch process and [indiscernible]. Our efforts during the quarter remain focus on site learning and hands on experience [indiscernible] Germany. Overtime, we expect to drive revenue as these burn centers compared from initial usage to confident and re-order. Operating expenses for the third quarter of 2014 were on plan at 4.5 million compared with 2.3 million in the same period of 2013. The increase was due to 1.2 million of commercial activities associated with building our European marketing infrastructure and executing our commercial launched program and $0.9 million increasing non-cash share based compensation expenses. Operating expenses for the first nine months of 2014 were $13.3 million compared with $4.5 million for the first nine month of 2013. The increase was primarily due to $3.6 million of commercial activities associated with building our European marketing infrastructure addition of $2.7 million increasing non-cash stock-based compensation expenses and about $0.5 million one-time IPO related expenses. For the third quarter of 2014, we reported a net loss of $5 million or $0.24 per share. The net loss for the nine month ended September 30, 2014 was $11.8 million or $0.61 per share. Our adjusted EBITDA for the third quarter of 2014 was loss of $3.7 million compared with the loss of $2.1 million for the same quarter last year. The resulted EBITA for the first nine months of 2014 was a loss of $10.3 million compared with a loss of $4.9 million for the same period last year. Turning now to our balance sheet; as of September 30, 2014 we have $69 million cash and cash equivalent and working capital total $70.1 million. We remain on track with regard to cash use and the company used $12.1 million in cash during the first nine months of 2014 to fund ongoing operating activities. As we have discussed we continue to invest in our marketing infrastructure and to advance commercial launches across Europe. We will also find further clinical development of NexoBrid and EscharEx. With that financial overview let me turn the call back to Gal. Gal please.

Gal Cohen

Management

Thanks for that overview Sharon. In conclusion, we remain focused on executing our strategy and had made significant progress towards our goal. We continue to expand our commercial efforts throughout Europe and to advance our clinical development programs. We have substantial market opportunities ahead of us both in severe burns and in chronic wound. And we’re eager to achieve several milestones during the fourth quarter and look forward to reporting to you on our next call. And now operator, please open the call for questions.

Operator

Operator

While we’re waiting for our first question I would like to note that Sharon and Gal will be participating in the upcoming Credit Suisse Healthcare conference taking place next week from November 10 to the 12th, in Phoenix, Arizona. The following there will be addressing investors at the Jefferies Global Healthcare conference which is taking place November 19th and 20th in London. For those of you attending either of these conferences and would like to meet with the team please reach out to your respective Credit Suisse or Jefferies representative or you can always contact me or Anne Marie Fields at LHA at 212-838-3777 and operator we’re ready for the first question.

Operator

Operator

Thank you. (Operator Instructions) And our first question comes from the line of Bruce Nudell of Credit Suisse, your line is now open.

Unidentified Analyst

Analyst

Hey guys, this is Matt in for Bruce, thanks for taking the question. First of all if you give us any color around how many centers you’re in, in Germany today using NexoBrid and how that compares to where you were maybe a quarter ago?

Gal Cohen

Management

I think [indiscernible] of the other centers in Germany which announced result in ’17 and what we see in the last quarter is the sense of but really we’re sitting on the fence and would starting to treat patients are now gradually starting to beat their hands into the water and stop chasing patients as well.

Unidentified Analyst

Analyst

So maybe 17 in the quarter and you’ve got to trained all the centers in Germany today.

Gal Cohen

Management

-- All your centers that can treat adults in Germany.

Unidentified Analyst

Analyst

Okay and then how many cases for those position that you saw you mentioned several seen reorders, how many cases or how long it take before those translated reorders?

Gal Cohen

Management

I think it takes certainly depends on several percentage from champions of champion but what we feel is that one big treats 5 to 10 patients they feel comfortable enough and go from experimental use of a testing technology to reordering and treating patients and as I mentioned within one sentence Germany particularly treated half of these patients so far and which we find is very encouraging.

Unidentified Analyst

Analyst

Okay, perfect and just one follow up and then I’ll drop, is that when you see - converting does that really efficacy based, is it a result of the economic argument that you’re making or what’s driving that?

Gal Cohen

Management

I think perfectly efficacy I mean the NexoBrid is particularly the ability to remove the eschar earlier without harming viable tissues and to allow the physician to [indiscernible] of the would bed and now get how to go about and treat the patient I think conditions realize that. The main challenges that they’re facing at the beginning are launch with the NexoBrid itself I mean they know how to use it, it’s not so difficult and it work so they see it remove the eschar it’s more about how to assimilate it to integrate it into - because they have been processing surgical - for the last 25 to 40 years and also effecting inline around that the eschar, the physiologist, the OT of the department and it take a bit of time specially in Germany that likes really to follow the protocols and integrate and understand how to best use the product in the daily routine. The economic element I think is more something that you can make sure that it’s not a show stopper rather than incentive to use the product. So the incentive is clinical and the economical benefit and any concerns of the administration of the hospital regarding the integration of the product into the use of its public center.

Operator

Operator

Thank you. And the next question comes from the line of David Maris of BMO Capital Markets, your line is now open.

David Maris

Analyst

Good evening, just one question on the update and we have - it’s not that much of a surprise that the sampling program that the trail program has taken kind of a more aggressive stand of getting physicians to try the product. So maybe you could just give us a little, is it taking longer to convert over a physicians from a trial to actual user and is that in part due to they’re starting off with the smaller burns and you had originally expected or is it getting procedures in the hospitals set for that physicians and other caregivers know what to be doing if they do decide to use NexoBrid? Maybe just talk a little bit about how the trial process has changed from your expectations from a ago?

Gal Cohen

Management

Thank you for the question. I think that’s first of all as I mentioned in the process going from awareness to interest from use to later on advocacy and we fill up awareness in Germany, I don’t think that you find the build center in Germany was not - you didn’t heard about the NexoBrid or interested in knowing more about it. And once we go into the training program and they get it interested they start experimenting the product, as we mentioned we provided the three products for them to experiment because we believe and we see this from our in market surveys that the more they use the product they’re more confident they gain and feel comfortable to integrate the product and start using it. What we see as we mentioned with unmet clinical study that you have exclusive [indiscernible] you said, you need to treat the patient’s wound and realize physician experiment start with the smaller patient because it also get comfortable with it and they’re not talking within the frame of a protocol so they have to create their own protocol nothing about these [indiscernible] just as we mentioned the integration of the treatment into their -- impacted and they usually started a small hence initially clinical advantage [indiscernible] and the broader hand they see after -- then they want to follow the patients for a couple of weeks until we will heal in the each patient. Only then they’re seeking and looking for the second patient to try the product and they do it with the couple of patients then additional physicians within the department and increasing their interest and want to try as well with their patients. During this process, where they treating the department five to 10 patients, the department experience start to…

Operator

Operator

Thank you. (Operator Instructions) And our next question comes from the line of Akiva Felt of Oppenheimer. Your line is now open.

Akiva Felt

Analyst

Thanks. I just had a first a follow up to David’s initial question. If you take the usage that you saw in Germany through the sampling program, if you have been charging commercial price, what would that equate to in terms of revenues?

Sharon Malka

Management

I think in general what we see and it will be -- just because of forward-looking statements and daily projections which we believe that it’s not the right thing to do during the launch phase, but if we just talk about evidence that is always be available. We said that in Germany most patients have been treated in the entire Phase 3 study. In the Phase 3 study, there is approximately 180 patients in the two-arm study. So it is what the [indiscernible] is and you end up with patients have been treated. We also said that, in general, we believe that average burn patients has about a 10% -- however will be experimental stage that starting to lose the product that using -- smaller burn so I would expect the [indiscernible] average we’re beginning to be bit lower than 10% and we know that we’re currently charging in Europe approximately a $450 pair 1% [indiscernible] So all the information there and one can get a good understanding for the question that you just mentioned.

Akiva Felt

Analyst

Okay. No, that’s helpful I’m sorry to put you on the start with the question. But would you say that the traction whether re-sampling or other programs have been in line or ahead of your expectations I mean it sounds like you guys are pretty happy with how things are going in Europe so far.

Sharon Malka

Management

I think there we see a lot of attraction, we see lot of interest, we see lot of enthusiasm in Germany. Our field was started to be on ground in the second quarter technically count the new option in July and August we got a time for launch introduction because all defenses are walking newly a capacity because of the vacation and they don’t to keep patient obviously but I don’t like to start new treatments during this time were half of the staff is not on board. We believe that we were able to gain a lot fair interest in use [indiscernible] this current sound of share has been there through the 70s. So we believe that gaining such interest getting so many centers to start treating in the new topic and new product. Since some centers going from total unawareness to awareness interest use in even efficacy seeing two physicians from Germany going to Australia to report real life usage of the product having one center already is a center of excellence inviting people from other countries and other centers in Germany to spend time ethic center to experience news of NexoBrid. Since a center in Germany that possibly in couple of months treated half of its patients with NexoBrid. So overall we are quite happy with what we see as well as with the extension to additional countries in the ratio of time been able advance the availability of the product to possibly and say half open we hope to complete this process in the next quarter. What we also see and this also not comes to surprise to us and we have communicated very clearly during the IPO and after the IPO we do not believe that NexoBrid will not found care with the new office.…

Operator

Operator

Thank you and I am showing no further questions at this time. I would like to turn the call over to Gal Cohen for any closing remarks.

Gal Cohen

Management

Thank you very much. First of all thank you for questions and for your interest in MediWound. We look forward to updating you again when we report our fourth quarter and full year 2014 results in early 2015. Thank you very much and have a good evening.

Operator

Operator

Ladies and gentlemen thank you for participating in today’s call. This does conclude the program. You may all disconnect. Have a great day everyone.