MediWound Ltd.

Good day and welcome to MediWound's first quarter 2024 earnings call. Today's conference is being recorded. If you require operator assistance, please press star then zero. At this time, I would like to turn the conference over to Dan Ferry of LifeSci Advisors. Please go ahead.

Thank you, operator, and welcome, everyone. Today, before the market opened, MediWound issued a press release announcing financial results for the first quarter ended March 3, 1, 2024. You may access that release on the company's website under the Investors tab. With us today are Ofer Gonan, Chief Executive Officer of MediWound, Honey Luxemburg, Chief Financial Officer, and Barry Wolfenson, 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 are including the Q&A session, relating to MediBloom'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 the results are subject to risks and uncertainties that could differ materially from those forecast due to the impact of many factors beyond the control of MediBloom. 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 the risk factors set forth in Meadowood's annual report filed with the SEC for factors that could cause actual results to differ materially than those anticipated in the forward-looking statements. The conference call is 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. Welcome to MediWound's first quarter 2024 earning call. Joining me today are Hani Luxemburg, our Chief Financial Officer, and Barry Wolfensohn, our Executive Vice President of Strategy and Corporate Development. After a presentation of the financial results and business updates, we will open the call for your questions. During the first quarter, we were laser focused on executing our strategic plan. At the beginning of the year, we set three major goals. First, to accelerate NEXObreed revenue growth. Second, to complete the construction of our new manufacturing facility by mid-year. And third, initiate the SCRx Phase III clinical trial in the second half of 2024, for which we already established collaborations with the most prominent wound care companies. I'm pleased to report that we are on track to achieve all these targets. I'm also excited to announce that according to a preliminary list of additions posted on May 24th, we are set to join the Russell 3000 index as part of the 2024 Russell indexes reconstitution. This inclusion will also grant us automatic membership in the small cap Russell 2000 index. Being included in these indexes, is a significant milestone enabling our visibility and reach within the investment community. Now let's move for the first quarter highlights and recent developments. NexoBridge overview. This quarter has showcased significant achievements for NexoBridge, aligning with our strategic goals. We have secured orders that meet our annual revenue projection of 24 million, with five million realized this quarter. In the United States, our collaborations with VeriCell has been very productive. Over 60 burn centers have submitted applications to their P&T committees. Approximately 40 have received approvals, and more than 30 centers have placed initial orders. VeriCell has reported substantial increases in both the number of patients treated with NexoBRED and the number of orders from burn centers and hospitals. Internationally, the adoption of NexoBreathe in Europe, Japan, and India through our partnerships with Polymedics, Kaken Pharmaceuticals, and BSV continue to show promising growth. These markets are instrumental in driving broader interest and use of NexoBreathe. Additionally, we have seen a continued increase in demand for Nexobrid in treating military casualties due to the ongoing war in Israel. Dozens of lives of soldiers and civilians were saved. The positive outcome achieved with Nexobrid have generated interest for many governments for future stockpiling. To meet this surging demand, we are actively enhancing our manufacturing infrastructure. Construction of our new GMP-compliant state-of-the-art facility is progressing on schedule to be completed by mid-2024, with commissioning set to begin in the third quarter of this year. The facility is expected to be fully operational in 2025, increasing our manufacturing capacity six-fold. Regarding additional growth drivers, The FDA has accepted our supplemental BLA for pediatric use with the decision expected in the second half of this year. It is worth noting that NexoBRED is already approved for pediatric population in Europe and in Japan. Our partnership with the U.S. Army is advancing as planned, focusing on the development of temperature-stable formulation for NexoBRED. We anticipate FDA's feedback on the product development path in the second half of this year. This project, bolstered by a $13 million grant from the Department of Defense, underscores the strategic importance of NexoBREAD in field care burn treatments. Lastly, we continue to generate further data to support NexoBREAD use. Our expanded access treatment protocol has successfully treated 239 burn patients across 29 US sites. With enrollment and 12-month follow-up now complete, we are ready to begin data analysis with findings to be published in the second half of 2024. Overall, the increasing global demand and our strategic expansion of the manufacturing capabilities along with the broadening scope of indications, positioned NexoBREAD to establish a new standard of care in eschar removal for severe burns. We are very pleased with NexoBREAD performance and the ongoing progress in all those areas. Now I'll provide an update on Escharex, our innovative bioactive therapy for venous leg ulcers and other chronic wounds. We have successfully manufactured the clinical batches and are on schedule to submit the final protocol for our Phase III trial in the first half of 2024. The trial is set to commence in the second half of this year. The Phase III study, mirroring the successful design of our Phase II trials, will be structured as a multicenter, prospective, randomized, and placebo-controlled global trial. We aim to enroll 216 patients across 40 sites, focusing on two co-primary endpoints, the incidence of complete debridement and the incidence of wound closure. An interim assessment will be conducted after 67% of the participants complete the trial, providing early insights into the efficacy of Escarex. This study has garnered significant interest from prominent companies in the wound care space, resulting in established research collaborations with Solventum, Molnicki, and Mimedix, leaders in compression therapy, advanced wound care settings, and dressings, I'm sorry, and tissue-based products. SKRx has also attracted a lot of attention at three major annual wound care conferences, the Wound Healing Society, the Symposium of Advanced Wound Care, and the European Wound Management Association. Strong Phase II data was presented, demonstrating Escorex's superiority over Santil, the current market leader, with more than $360 million in annual U.S. sales. Recently, there has been a significant discussion about the proposed changes in Medicare reimbursement for cell and tissue-based products. If implemented, these changes will have major impact on the wound care industry and will greatly benefit escarex. We are not surprised by these changes. We anticipate that the market share will shift from smaller companies without strong clinical evidence to larger established companies. Additionally, one of the key changes is to limit the number of tissue units that can be applied to a wound requiring more attention to the condition of the wound bed prior to initiating tissue applications. Escarex excels in this area. It is not just debridement, but it also quickly prepares the wounds for application of tissue. Our phase three study is perfectly aligned with this. as we aim to secure a claim for preparing a wound for active closure. Generally, as the market value of tissue therapies decreases, the relative value of biologic drugs with a blockbuster potential will increase. SKRx is going through a rigorous BLA process backed by extensive and robust trial data and entering into a category that has just stable reimbursement for decades. become an even more valuable asset when these policies become effective. In conclusion, F-Corex is poised to become a leader in the biologic sector of the advanced wound care market. Our data to date showcases its superior efficacy in debridement, wound closure preparation, time to wound healing, biofilm removal, and bacteria reduction, highlighting its versatility and utility. The comprehensive clinical and health economic data that we are generating in the phase three study will further solidify SCRX's strong position within the industry. Now, I'll hand it over to Hani to briefly review our financials. Hani?