MediWound Ltd.

Ladies and gentlemen, please stand by. Your conference call is scheduled to begin momentarily. Thank you for your patience and please continue to stand by. Thank you. Thank you. Thank you. Thank you. Thank you. Ladies and gentlemen, thank you for standing by, and welcome to the Q3 MediWound 2020 conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised, today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Jeremy Pfeffer. Please go ahead.

Thank you, Sydney, and good morning, everyone. Earlier today, MediWound issued a press release announcing financial results and provided a business update for the third quarter of 2020. You may access that release on the company's website under the Investors tab. With us today are Sharon Malka, Chief Executive Officer of MediWound, and Boaz Gorlavi, Chief Financial Officer. Following management's prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session, relating to Meadowood's expected future performance, future business prospects, or future events or plans are forward-looking statements as defined under the Private Security Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, Actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecast due to the impact of many factors beyond the control of MetaWars. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to cautionary notes set forth in today's press release, as well as a risk factor set forth in MediWound's annual report filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. This conference call is the property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. Now, I would like to turn the call over to Sharon Malka, Chief Executive Officer. Sharon?

Thank you, Jeremy. Good morning and good afternoon to our listeners in Israel. Thank you everyone for joining us today on our third quarter 2020 earnings call. We are proud of our third quarter achievements as our team continued to navigate through the challenges of the COVID-19 pandemic. We are very pleased with our third quarter financial results as we generated strong revenue growth compared with prior year driven by the procurement of NexoBREAD by BARDA for emergency response preparedness. In addition, the third quarter was highlighted by several important milestones towards our goal of providing NexoBREAD as a new standard of care for eschar removal in patients with severe burns. First, the FDA accepted the NexoBREAD BLA and provided us with a PDUFA target date in mid-2021. Second, the DETECT study was completed, and the 24-month patient follow-up safety data was comparable across all arms. Third, we completed the patient enrollment stage in the NexoBridge pediatric study, and lastly, continue to enroll burn patients in the next expanded access protocol. In the Escarex program, we continue to actively recruit patients in our US Phase II study for treatment of venous leg ulcers, and we initiated pharmacology studies to explore additional clinical benefits of Escarex. We continue to address challenges associated with the COVID-19 pandemic while prioritizing the health and safety of our workforce and maintaining operational efficiency and flexibility. While COVID-19 continues to cause considerable uncertainty, we expect to maintain growth and we are optimistic that we remain on track to strengthen our company further. Let me now provide some more color on our recent achievements and review of our third quarter highlights. We are pleased to see product revenues growing and the global expansion of NexoBREED to new territories. We generated strong revenue growth in the third quarter, primarily as a result of BARDA acceptance of the first shipment of NexoBREED as part of its mission to build national preparedness for public health emergencies. The first shipment represents a major milestone in our long-standing partnership with BARDA. As a reminder, the initial BARDA procurement of NexoBREED is valued at $16.5 million, and we expect additional quarterly prorated deliveries and revenues from this procurement throughout the end of 2021. In September, the U.S. FDA accepted for review our BLA submission for NexoBREED for ESCA removal of deep partial thickness and full thickness burns and assigned a PADUFA goal date of June 29, 2021. This represents a major milestone in the path to bringing NexoBREED to market in the U.S. and we look forward to working together with BARDA, VeriCell, and the FDA during the regulatory review process. We are pleased to report that we completed the US Phase III Detect Study, including the collection and analysis of the long-term patient follow-up safety data. As a reminder, in early 2018, we announced the results of the US Phase III Detect Study which were robust across all endpoints. The study met its primary endpoint and all of its secondary endpoints. Subsequently, we reported a 12-month follow-up safety data, which was comparable across all study arms with no safety signals observed. The 24-month safety data of cosmesis, function, and quality of life was again comparable across all study arms, the NexoBREAD arm, gel vehicle, and the standard of care arm. Additionally, the overall safety profile of NexoBREAD was consistent with the previous data and no new safety signals were observed. As agreed with the FDA in our pre-BLA meeting, we plan to submit the 24-month safety data as part of a post-approval commitment. We recently announced the completion of the enrollment stage of the phase three NexoBREAD pediatric study, KIDS. Completing the enrollment stage of the KIDS study is an important step towards our goal of providing NexoBREAD as a treatment option for pediatric patients with severe burns, giving NexoBREADs potential to address the unique challenges in treating children with severe burns with the current standard of care. We anticipate reporting top-line results from this study, including the 12-month follow-up data during the second half of 2021. As we await FDA review, we continue to enroll patients in our NexoBridge Expanded Access Program next, To date, 22 U.S. burn centers were trained with a majority actively treating burn patients, and we expect to activate additional clinical sites before year-end. We see increase of the use of NexoBREED with more burn patients treated in more burn centers across the U.S. The completion of the kids' enrollment stage followed the FDA's agreement to allow the NexoBRED expanded access protocol to be expanded and to include pediatric as well as adult patients. The inclusion of pediatric patients in the next protocol will allow additional physicians to expand their experience with NexoBRED in pediatric patients and expand the national capacity of trained physicians. The next program, importantly and strategically, keeps us engaged with the key burn centers in the U.S. as our U.S. commercial partner, foreign exobreed Varicell, is actively preparing for commercial launch, as discussed in detail during the recent Analyst and Investor Day. We were encouraged by the KOL's enthusiasm for an exobreed effect, and how, upon approval by the FDA, it could change the treatment paradigm for ESCA removal of severe thermal burns. VeriCell provided an overview of the potential market opportunity in the U.S., estimating a total addressable market of over $200 million. with a target of 140 burn centers across the U.S., most of which are already VeriCell customers. In addition, VeriCell reviewed its extensive ongoing pre-launch and medical initiatives, which include significant expansion of its burn sales team, development extensive education and support plans, and cost effectiveness and pricing analysis. Let me now shift gears and update you on the escharic development program. We continue to actively recruit patients in our Phase II US study for the treatment of venous leg ulcers in compliance with applicable governmental orders and clinical site policies and procedures, as we expect an interim assessment toward mid-2021. Since the reinitiation in June, we continue to initiate new clinical sites across the U.S., and we currently have 25 clinical sites open and ready to enroll patients, with the majority having already begun enrollment. While considerable uncertainties related to COVID-19 remain, we expect to add additional clinical sites in the U.S. before year-end, and our team continues its efforts to have additional clinical sites out of the U.S. We also believe that SKRx can provide additional clinical benefits and address other areas of unmet medical needs where enzymatic debridement can be helpful, such as reduction of biofilm burden. there is a consensus among clinicians that biofilm and aggregates of microorganism encapsulated in a self-created matrix contributes to delay in wound healing and that it may be possible to use enzymatic debridement agent such as Escarex to promote improved healing. Multiple preclinical studies have reported that enzymes, including bromelain, show PROMIS as an effective treatment for reduction of the biofilm burden, independent of its debridement capabilities. As part of our initiative to explore the pharmacological effect of Escarex, we have initiated pharmacological studies to assess the effect of Escarex on biofilm burden, as well as other clinical effects associated with chronic wounds. We look forward to sharing more details with you about our development plan in this area in the near future. Let me now turn the call over to Boaz for a summary of our financials for the quarter.