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MediWound Ltd. (MDWD)

Q3 2015 Earnings Call· Wed, Oct 28, 2015

$16.36

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Transcript

Operator

Operator

Good day. And welcome to the MediWound Third Quarter 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. Please go ahead madam.

Anne Marie Fields

Management

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, Chief Executive Officer; and Sharon Malka, Chief Financial and Chief Operations Officer. After the closing of the stock market yesterday, MediWound announced financial results for the three months ended September 30, 2015. If you have not received 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 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, October 28, 2015. 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

Chief Executive Officer

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. The third quarter was a time of tremendous focus for MediWound highlighted by three main events. The award of contract with the U.S. Biomedical Advance Research and Development Authority or BARDA, to support the development and procurement of NexoBrid, for preparedness in the event of mass casualties, the completion of the patient enrollment for our Phase 2 EscharEx clinical trial for the treatment of chronic wounds, and the positive market use of feedback around NexoBrid at the recent European Burns Association Congress or the EBA. Let me begin with a review of the progress we've made in Europe commercializing NexoBrid for the treatment of severe burns and about the EBA. We continue to train additional burn center facilitated the use of NexoBrid by additional centers and accelerated the overall treatment of burn victims with NexoBrid. During the last nine months, we made significant inroads into training burn center across Europe and walking with these centers to integrate Nexo reviews into the workflows. We can now say, that almost 80% of our initial target burn centers in Europe have been trained and over 60% of these trained burn centers started to treat patients with NexoBrid. In parallel, we continue our efforts to obtain reimbursement knowing that it is an important component for widespread adoption and for converting the growing usage of NexoBrid into revenues. As previously reported accompanied by a local market experts, the local investment processes are ongoing through the different stages in all the applicable markets and we are looking forward to reporting our progress over the coming quarters. I would like to share…

Sharon Malka

Chief Financial Officer

Thank you, Gal. Good morning everyone and thank you for joining us for our quarterly financial review. The third quarter has been a very productive time for MediWound. In particular the parallel contract which will positively affect our financials, both by offsetting our NexoBrid development cost and by contributing to our revenue line as a result of the procurement commitments. For the balance of the year, we will continue to invade in training and sampling programs throughout Europe, as well as in market excess initiative that we expect to result in favorable reimbursement that will help to accelerate market adoption, and will enable us to translate the positive momentum into sales. Now let me turn to our financial results for the third quarter of 2015. Revenues for the third quarter of 2015 were $102,000 compared with $46,000 for the same quarter last year. Operating expenses for the third quarter of 2015 were in line with the Company's budget of $3.6 million compared with $4.5 million for the third quarter of 2014. The decrease was primarily due to 0.6 million decrease in non cash share based compensation expenses and an increase of participation by the Israeli office of the Chief Scientific Officer in our R&D cost. Net loss for the third quarter of 2015 was $3.8 million or $0.17 per share compared with a net loss of $5 million or $0.24 per share for the third quarter of 2014. The decrease in loss was primarily due to non cash net financial income. Adjusted EBITDA for the third quarter of 2015 was a loss of $3.6 million compared with a loss of $3.7 million for the same quarter last year. As noted in our 6-K, we believe that this non-IFRS measures are useful for investors and provide meaningful supplemental information regarding our…

Gal Cohen

Operator

Thank you, Sharon, for the financial overview. We are very excited about the opportunities ahead and we are getting closer to the end of the year and look over 2016. We are looking forward to working with BARDA towards availability of NexoBrid in the U.S. and we have a number of value creating milestones in front of us including the very near data result from our Phase 2 EscharEx study and some key reinvestment decision in Europe, as well a further expansion into new market and territories. And now, operator, please open the call for questions.

Operator

Operator

[Operator Instructions] And we'll take our first question from Anthony Petrone of Jefferies. Please go ahead.

Anthony Petrone

Analyst · Jefferies. Please go ahead

Thanks, gentlemen, and good afternoon and good morning. Maybe first to start on the BARDA contract, the first - just to get a little bit more color on the timing of flow of funds on that contract, so the first $24 million funding, can you just provide a little bit of timing on when that occurs? And then secondly, what actually triggers the additional expansion options under that contract? Does the Company have the safety initiative and then expanding to other indications, or will FDA actually request other indications over time and that will sort of facilitate the additional funding under that contract? And I have a couple of follow-ups, thanks.

Gal Cohen

Operator

Thank you, Anthony. So, in terms of the contract, the first $24 million for supporting our R&D efforts is a back-to-back reimbursement of our expenses. So, every quarter or every month as we spend money to advance NexoBrid toward U.S. registration, we sent BARDA the expenses and date, and data for debt expenses and this effect is immediate as you can already see in the spin in the current quarter where we have, or in next quarter we can see in our expected cash burn until the end of the year. As for procurement, the $50 million are contingent upon obtaining one of the following. EUA BARDA obtained what is called an emergency use authorization, which is something that BARDA can ask in order to stockpile a product for emergency use. So, this is not for commercial use, it's for an emergency use. In order to do that BARDA needs to submit a request and from what we have learnt or have been advised, this is a positive, it can one to two years and in the vast majority of the cases subject obviously to FDA review and approval and BARDA is able to do that. So, it means that BARDA has a binding commitment to buy NexoBrid for $60 million within the period of the contract. In addition to that, BARDA has several other options. One option is to fund for $22 million additional indications, for example, if MediWound submits a protocol to the FDA or include children in the FDA study, BARDA will have an option to fund this activity as well. We have discussed with BARDA and unfortunately one cannot preclude a situation that children would be affected in a dreadful mass casualty event in the U.S. and if unfortunately they are, we need the centers that treat pediatrics in the U.S. to be prepared for such an event, and the only way to getting prepared for such an event is to have the product on ground and to have the teams practice the use of NexoBrid. So, this is the motivation behind these options. The option for the $50 million for further procurement again is an option of BARDA, BARDA can at any time decide the date within the framework of the contract, so they have a limited time to make a decision that they want to procure more than $60 million and they can go up to another $50 million of procurement of the product in a fixed price and so on.

Anthony Petrone

Analyst · Jefferies. Please go ahead

That's helpful. Yes, very much so. That's helpful. And maybe just a follow up on actual usage in European sites and some color at EBA, so at current sites, can you give us the sense of what types of burns that you're seeing NexoBrid used in, is it burns that are in a small body surface area, say less than 15%, or you're actually seeing it being used in larger burns at some of the active sites? And then again just at EBA, any discussions on cost effectiveness studies that you can point us to that would helpful. Thanks again.

Gal Cohen

Operator

Thank you. So, as for larger burns, I think this is an excellent question. As you know the average burn patient in the clinical studies or if you go to the NBR, which is a huge database, would be around 10% total body surface area, which means that we would need to providing with 20 grams of NexoBrid, which would amount to a cost of about $5,000. When centers to Europe start to treat patient and again it depends on different centers and different countries having different approaches to innovation I would say, but in general they usually start with a small burn, they start with the hands for example, because the hand is a small burn and 1% TBSA burn in an area that is very challenging to do surgery on, in an area where cosmetics and functionality is highly important, so this is where they feel comfortable starting and then they expand from there. Our efforts are to get centers they did not start to start, to get the centers started to use the product on more patients and to get centers that use the product on more patients to expand the use of the product to larger areas, because for us if a physicians treats, let's say 10% TBSA, 10% of the total body surface area of the patient, that's like treating 10 patients with hand. And we believe that one of the surface of growth and revenues will come exactly from that, and this is a natural process. And we already see centers for example that are moving towards that direction. I cannot give you the exact information but I can tell you that we've just seen in the last week centers in Europe treating patients to the maximum of the label indication and some would save and beyond. So this is a good question. As for cost effectiveness, we did - not we, but experts in Europe did present in EBA papers about a cost effectiveness of NexoBrid, and as I said we had 26 presentation given by individual, independent burn specialist in Europe. I personally have not participated in a conference where 26 presentations were given on a single product in international conference and some of them would offend to cost effectiveness, these abstracts are available and [indiscernible] said it to you, but there is a link towards the abstract and you can go and see exactly what will sell. In general, the conclusion of the auto world, this NexoBrid is a cost effective treatment that saves money to the hospital.

Anthony Petrone

Analyst · Jefferies. Please go ahead

Thank you.

Operator

Operator

[Operator Instructions] And as there are no further questions remaining, that will conclude today's Q&A session. I would now like to turn the call back to Mr. Gal Cohen for any final closing remarks.

Gal Cohen

Operator

I just wanted to say thank you for your questions and for your continued interest in MediWound. We look forward to updating you again when we report our fourth quarter and yearly financial results. Have a good day, thank you very much.

Operator

Operator

That will conclude today's conference call. Thank you for your participation ladies and gentlemen. You may now disconnect.