Gal Cohen
Analyst · SunTrust. Your line is now open
Thank you, Anne Marie. And thank you all for your interest in MediWound and for participating in today's call. Following on the momentum we had in the first quarter, the second quarter of 2016 continued to be another quarter of significant achievement for both our commercial and clinical programs. We continued to grow the number of burn centers treating more burn patients with NexoBrid in Europe, obtain reimbursement for NexoBrid in Italy, expanded global distribution of NexoBrid in Argentina, where NexoBrid was launched and to Japan with an exclusive agreement with Kaken Pharmaceuticals and we initiated the second court of the second Phase 2 study of EscharEx to allow patients even more flexibility in using EscharEx in a place and time that best suits their individual daily routine. Let's start with a view of our ongoing commercial progress with NexoBrid in Europe. I will walk with burn specialist and burn centre across Europe continues to bear fruit as we are seeing increasing adoption and previously treating centers are treating more and more centers and we see an increase in the number of treating centers. We have done a good job creating interest in NexoBrid and educating burn specialist. As most centers are integrating NexoBrid into their workflows, we see a growing number of patients being treated and were feasible initiating a growing revenues. Securing national and regional reinvestment, we acquired - remains s a critical component for the last scale adoption of NexoBrid as the new stand of care for debridement of severe burns. We continue to work closely with clinicians, market access professionals, and government agencies to obtain reimbursement, in their applicable countries, and to gain formulary inclusion at the hospital and at the regional level. During the second quarter, we were pleased to report that that Italian Drug Agency AIFA approved the pricing and reimbursement conditions for NexoBrid for removal of EscharEx in patients with deep partial and full-thickness thermal burns. The approved pricing is again in line with the opinion list price for NexoBrid. With national reimbursement now in place in Italy, we are working on a formulary inclusion at the hospital in regional levels, with a goal of firmly establishing NexoBrid as the stand of care in Italy and converting the increasing use across the vast majority of burn centers in Italy into revenues. Our commercial efforts continue to be supportive by the significant presence we have at international and regional medical conferences for burn specialist, where we continue to gain support from KOLs and champions while generating clinical data and sharing their hands on experience using NexoBrid to treat severe burn patients. In early May, we had a strong presence at the American Burn Association Meeting where 11 papers highlighting the merit of NexoBrid were presented. In addition, the burn centre that pioneered the development of laser Doppler imaging is a diagnostic tool in the assessment of burn depth and severity presented the study on the ability of NexoBrid to allow early direct assessment of burn severity compared with laser Doppler imaging and [Artwork] [ph] was awarded the best oral presentation at the recent British Burn Association meeting. Throughout the balance of the year, we will continue to support the advancement of burn care by sponsoring additional international, European and regional burn conferences. So at that end, we look forward to the annual international society of burn injuries meeting being held in Miami at the end of August. And again, we expect a good number of abstract would be presented in support of NexoBrid use to debride severe burns. This is an important meeting because it draws a diverse international audience of burn specialist. We continue to advance our ongoing U.S. Phase 3 clinical program for NexoBrid in collaboration with BARDA and enjoy the collaborative work with BARDA's U.S. experts. As part of the joint effort to advance U.S. preparedness for mass casualty incidences, we look forward to further increasing the experience of U.S. burn centers, in tweaking severe burn patients with NexoBrid. Turning now to our progress expanding NexoBrid into other global market. During the second quarter, we made significant progress advancing our strategy to leverage our EMA marketing authorization to expand NexoBrid internationally. We are very pleased to report that our distributable partner in Argentina launched NexoBrid during the second quarter as planned and look forward to professionally support them as they expand access in Argentina to local awareness, interest, use and advocacy. We were also pleased to join and sign an distribution agreement with Kaken Pharmaceuticals for distribution of NexoBrid in Japan. Kaken Pharmaceutical is a company with over $1 billion of files and has a leading position in wound care in Japan. They have a considerable regulatory market access and sale capabilities, so we are very happy to help Kaken as a partner in this important market. Our distributions partners have already submitted registration files in Mexico, in South Korea, and in Russia and we are preparing to do so in additional countries in South America, India and Japan. We look forward to updating you on the progress towards approval and commercial launches. We continue to seek potential distributor partners in other important markets and we look forward to providing you with further news on this front as well. Now, let's turn to a discussion of our progress with EscharEx, our treatment for chronic and hard-to-heal wounds. In February, we reported positive top line results from our second Phase 2 clinical trial evaluating EscharEx for the treatment of chronic and other hard-to-heal wounds. The positive data in post-hoc analysis from our Phase 2 clinical study with EscharEx encourages us to advance this very promising product in diabetic foot ulcers and venous leg ulcers which represents a tremendous market opportunity. We were particularly pleased to have this compelling Phase 2 data presented as a late breaker at the SAWC Spring conference in Atlanta before an audience of leading wound care specialists. Stakeholders at the conference were very interested to hear that 93% of the wounds which completed the driving with EscharEx were debrided within 7 days after nearly four to five applications on average. This is particularly compelling when you consider the topical debridement treatments currently on the market require daily applications for weeks and months to achieve complete debridement, yes they still sell in the U.S. alone 100 of millions of dollars every year. Enrollment of the second court of 24 patients to demonstrate safety after extended application period is ongoing. This second quarter is also a multi center perspective randomized vehicle controlled assessor-blinded blind study in which 24 patients in two different wounded theologies diabetic foot ulcers and venous leg ulcers are randomized to EscharEx or the gel vehicle at the 2-to-1 ratio. The product is applied for an extending period of time 24 hours, or 48 hours with the main objective to document safety after extended application periods to further contribute to the products convenient application by allowing patients even more flexibility in using EscharEx in a place and time that best suits their individual daily routine further enhancing ease-of-use and compliance. Recruitment should be completed in the coming months and we expect to have top line results from this second quarter of patient in the fourth quarter along as to approach the FDA by year end in order to establish plans for pivotal program that would support a BLA submission for EscharEx. It is also important to note, that EscharEx indication is for debridement of wounds. So it is complementary with the numerous market technologies that are aiming to heal this wounds. We see a number of potential synergies with this product and expect that they will be used sequentially in clinical practice. EscharEx represents a very meaningful market opportunity. So expanding into the wound care market with EscharEx continues to be an important next step in our strategy to build shareholders value by leveraging our proprietary technology. In addition to EscharEx, we are delighted to be achieving or advancing MWPC003 what we call MediWound 003 agent and injectable form of our technology for the treatment of connected tissue disorder. Our injectable bromelain solution agent is an investigational sterile injectable drug containing a mixture of medical-grade proteolytic enzymes as used in NexoBrid and in EscharEx. In May we reported that a comprehensive view of MWPC003 for the treatment of Dupuytren's contracture was published in a peer-reviewed journal, Bone & Joint Research. An XO study was conducted in 71 courts that were injected with our 003 agent in descending doses. This study demonstrated that even very small doses of our agent can dissolve the pathological code in more than 80% of the cases. The scientific rational for 003 to treat connected tissue disorders is based on this patriotic properties which allows us to dissolve the pathological code even when using very small doses and the potential for their reported anti-inflammatory activity of bromelain to reduce the high recurrence rate. We are enthusiastic about this opportunity as this preliminary study demonstrated statistically significant efficacy in a known and accepted connected tissue order model and supports additional new potential uses of our enzymatic technology. With that overview of our commercial and clinical programs, let me turn the call over to Sharon Malka, our Chief Financial Officer for a review of our financials. Sharon?