MediWound Ltd.

Good day and welcome to the MediWOM third quarter 2024 earnings call. All participants will be in a listen-only mode. Should you need assistance, please signal conference specialists by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. And to withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Mr. Dan Ferry of Life Advisors. Please go ahead, sir.

Thank you, Operator, and welcome, everyone. Today, before the market opened, MediWound issued a press release announcing financial results for the third quarter ended September 30, 2024. You may access that release on the company's website under the Investors tab. With us today are Ofer Gonen, Chief Executive Officer of MediWound, Honey Luxenberg, Chief Financial Officer, and Barry Wolfensohn, Executive Vice President of Strategy and Corporate Development. Following our 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 MediWOON's expected future performance, future business prospects, or future events or plans are forward-looking statements, as defined under the Private Securities 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 MediWound. The company assumes no obligation to update or supplement any forward-looking statements, whether 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 the risk factors set forth in MediWound's annual report filed with the FCC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. The 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 Ofer Gonin, Chief Executive Officer of MediWound. Ofer?

Thank you, Dan, and good morning, everyone. I appreciate you joining us today to discuss MediWound's performance and progress during the third quarter of 2024. This has been a strong quarter for MediWound, marked by meaningful achievements that contribute to our long-term growth and advances us closer to realizing our vision. Let me start with an update on Nexobrid, our innovative enzymatic therapy for severe burns. This quarter, we reached a significant milestone with FDA approval on Nexobrid for pediatric use in the United States, expanding its label to cover patients from newborn to 18 years old with deep partial thickness and full thickness thermal burns. This approval solidifies Nexobrid status as a treatment option for all age groups in the United States, bringing its indications in line with those in the European Union and Japan. Commercial revenue of NexoBridge has met expectations limited only by our existing capacity constraints. In the United States, NexoBridge continues to make substantial progress thanks to various self-dedicated commercialization efforts. More than 70 burn centers have already made P&T committee submissions, of which approximately 50 are already securing approval and placing initial orders. Additionally, NexoBridge recently received a Category 3 CPT code, which is scheduled to be posted on the AMA website January 1st and go into effect July 1st next year. VeriCell has also reported an impressive 43% quarter-over-quarter increase in revenue of NexoBridge, reflecting its expanding impact in the United States burn care market. We are also excited to share that the World Health Organization, WHO, has recently designated enzymatic debridement as an essential treatment for burn injuries in its standard recommendation for burn care in mass casualty incidence guidelines. This reinforces NexoBreathe's crucial role in emergency response and global preparedness and strengthen ongoing initiatives to develop strategic stockpiling of NexoBREED in the European Union, building on the successful precedent set by BARDA in the United States. As we shared before, we have also completed construction of our state-of-the-art GMP compliant manufacturing facility with commissioning currently underway. The facility is expected to reach full operational capacity by the end of 2025 and to increase our manufacturing output six-fold. Commercial availability will be contingent upon obtaining the necessary regulatory approvals. The company anticipates $20 million in revenue for 2024, compared to prior guidance of $24 million. NexoBrit product revenue remains in line with expectations, driven by strong demand that well exceeds current manufacturing capacity. However, the FDA approved NexoBridge pediatric indication without requiring any additional post-approval activities. This eliminates the need for BARDA funding for such activities and reduces the associated revenue. Additionally, following a Type C meeting with the FDA, clinical activities for the temperature-stable formulation of Nexobrid for the U.S. Army have been scheduled for 2026, which postponed the associated contribution from the U.S. Department of Defense. To conclude, demand for Nexobrid continues to grow, driven by U.S. expansion via VeriCell, FDA pediatric approval, and inclusion in the WHO BMCI Guidelines. Our new GMP facility, set to increase capacity six-fold, will support this rising global demand and revenue growth. I will now turn to Escarex, our advanced enzymatic debridement therapy for chronic wounds. We have completed all preparations for the upcoming Phase III study of Escarex in venous leg ulcers, marking a major step forward in addressing an unmet need in the two billion chronic wound debridement market. The study is set to commence with IND submission planned by year end. This pivotal trial will evaluate the efficacy and safety of SCRx and aims to establish it as a transformative treatment for VLUs. All setup activities for the trial have been finalized, including successfully passing the required EMA inspection ensuring compliance with regulatory standards and readiness to initiate the study. To provide insight into this upcoming Phase III study and to the broader commercial potential of SCRx, MediWood will host a virtual Key Opinion Leader event on January 8, 2025. During the event, experts will discuss the trial design, objectives, and highlight SCRx's anticipated impact on patient outcomes. In parallel, we are working with a third-party research firm on a comprehensive market analysis to refine our understanding of the potential market share, target segments across various scale settings, pricing strategies, and projected peak sales. We look forward to sharing the findings of this analysis alongside expert perspectives during these KOL events. In addition, we are preparing to launch a randomized head-to-head, face-to-face study of SCRx versus collagenase in 2025. This trial is designed to support our BLA submission and further establish SCRx's competitive advantages. This study will enroll 45 VLU patients across multiple sites in the United States and Europe. Participants will be randomized into a one-to-one-to-one ratio to receive escarex, placebo, or collagenase, which is marketed in the United States as Santil and in Europe as Iruxol. Over a 14-week period, the escarex and placebo groups will receive up to eight daily applications during the first two weeks, while the collagenase group will follow the product-specific instructions for use. The trial will evaluate key safety endpoints, including the incidence of severe advanced events and time to complete wound closure, as well as other efficacy endpoints, such as time to complete debridement and wound bed preparation. To ensure consistency and optimize patient outcomes, the study standardizes wound care and compression management, made possible through strategic research collaborations with Solventum and Molnicki. We have also obtained 16.25 million euros in funding from the European Innovation Council to advance the development of Escarex for diabetic foot ulcers, accelerating our program timelines by four years. With over 1.6 million DFU patients in the United States requiring debridement each year, this funding will afford us the opportunity to bring a potential new treatment to these currently underserved patients facing the risk of amputations, infections, and death from DFU's complications. The preparation for the Phase 2-3 study in those patients are progressing well, and we're excited about the potential to impact, that S-Corex have impact on these improving outcomes for substantial patient population. So as for S-Corex, we are finalizing the IND submission for the VLU patients, setting the stage for the initiation of the Phase III trial. Furthermore, the upcoming head-to-head study comparing SKRx to collagenase alongside advancements in the recently funded DFU program will solidify SKRx's position as the leading solution to address critical unmet needs in the chronic wound market. Having summarized our significant progress with both Nexobrid and SKRx, I'd now like to highlight the key strategic and financial milestone. This quarter, we secured $25 million through a private investment led by Molniki Healthcare, which is a global leader in the wound care field. This strategic partnership provides not only critical funding, but also access to Molniki's extensive commercial expertise and regulatory insights, enabling us to advance our strategic plans with greater focus and momentum. Now, I'll hand it over to Hani to briefly review our financials.