MediWound Ltd.

Good day and welcome to Mediborne's fourth quarter and full year 2024 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist 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 telephone keypad. To withdraw your question, please press star then two. Please note today's event is being recorded. I would now like to turn the conference over to Dan Perry of Lifestyle Advisors. Please go ahead.

Thank you, Operator, and welcome, everyone. Earlier today, pre-market open, MedWound issued a press release announcing financial results for the fourth quarter and full year ended December 3-1, 2024. You may access this press release on the company's website under the Investors tab. I would ask you to review the full text of our four looking statements within this morning's press release. 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. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations that are described more fully in our filings with the SEC. In addition, all forward-looking statements represent our views only as of today, and Metawound assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. This conference calls the property of Metawound, and any recording or rebroadcast is expressly prohibited without the written consent of Metawound. With us today are Ofer Gunn, Chief Executive Officer of Metawound, Connie 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. Now, I would like to turn the call over to Ofer Gonan, Chief Executive Officer of MediWound. Ofer.

Thank you, Dan, and good morning, everyone. 2024 was a pivotal year for MediWound, marked by strong execution, significant progress in clinical development, commercial expansion, and strategic partnerships. These achievements have strengthened our position, enabling us to drive continued growth and innovation in 2025 and beyond. I'll begin with Escarex, our next generation enzymatic debridement therapy for chronic wounds. In early 2024, we reported compelling results from our head-to-head analysis against Sampyl. Currently the only FDA approved enzymatic debridement product in the United States, generating approximately $370 million annually. The data demonstrated escorex's superiority over Sampyl across key clinical endpoints, including higher incidence of complete debridement, faster time to complete debridement, more rapid and effective wound bed preparation, and faster time to wound closure. Clinicians surveyed across diverse pairings recognize these superior clinical benefits and the substantial value they provide. In fact, recently conducted market research estimates escorex peak sales potential at approximately $725 million for its primary indications, venous leg ulcers and diabetic foot ulcers. These clinical benefits also make SCRx well-positioned for upcoming changes in wound care reimbursement. Starting next month, Medicare's new LCD policy will require full wound debridement and granulation tissue formation before covering cellular and tissue-based products. This shift strengthens SCRx's opportunity as a major commercial opportunity for our company. SKRx now is in its third history. We recently launched a new global phase three trial to evaluate SKRx for venous leg ulcers, involving 216 patients across 40 sites in the United States and Europe. The co-primary endpoints of the trial are the incidence of complete bright and the incidence of wound closure. This program is strategically de-risked, building on the strong results of our phase two studies with key modifications to maximize the likelihood of success, modification that includes a larger patient sample size to strengthen statistical power, and interim analysis at 65% enrollment, allowing for adaptive adjustment, and standardized treatment protocols to minimize variability and ensure consistency. It is also important to note that Escarex shares the same active pharmaceutical ingredient as Nexobrid, which is FDA approved for a nearly identical indication, ESCA removal. The interim assessment, a significant milestone, is anticipated in mid-2026, with full trial completion expected by year-end 2026. To further strengthen our BLA submission and enhance commercial readiness, we are planning a 45-patient randomized prospective phase two head-to-head comparison of SCRx versus collagenase, scheduled to begin in 2025. This study will include both Santil and the European collagenase product, Iruxol, generating critical comparative data that will be instrumental in supply market access and pricing strategies. The VLU program is supported by strategic research collaborations with leading wound care companies, Solventum, Molneke, and Mimetics. These partners will provide advanced wound care products for our trials, ensuring optimized patient outcomes and standardized wound management across all sites. Additionally, earlier in 2024, we secured 16.5 million euros in funding from the European Innovation Cup. to accelerate the development of SKRx for diabetic foot alters. The Phase 2-3 DFU clinical trial is planned for 2026, and we are pleased to announce a new strategic research collaboration agreement with Keresys, a subsidiary of Coloplast, to support this effort. Keresys, which is a global leader in wound care solutions, will be supplying its fish skin graft for active closure in this trial. Additionally, we anticipate securing another collaboration with a major industry leader to supply their market-leading advanced wound care dressings. With these partnerships, Mary Wound will be working alongside all the relevant key players in advanced wound care, reinforcing our strong industry positioning. Now let's move to Nexobrid, our innovating enzymatic therapy for severe burns. Before we discuss our progress with Nexobrid, I want to take a moment to highlight its critical real-world impact. This past weekend, a devastated nightclub fire in North Macedonia claimed 59 lives and injured at least 155 people. a medical delegation from Israel equipped with NexoBridge immediately flew in to provide support and treatment. We are grateful that NexoBridge could play such a vital role in this tragedy. With that said, in 2024, we achieved significant progress in expanding NexoBridge's commercial reach, generating annual revenue of $20.2 million driven by robust global demand. Moving forward, we anticipate continuous strong growth with projected revenue of $24 million in 2025, capped only by our manufacturing capabilities. This growth will be driven by expanding sales in key markets, Europe, where NexoVid is now available in more than 90 burn centers, Japan, where our partner, Kaken Pharmaceutical, has achieved a remarkable adoption with 400 plus medical facilities using NexoBridge and the United States where various health strong commercialization efforts yielded a 42% increase in hospital orders in Q4, 2024. NexoBridge market's potential was further expanded with FDA approval for pediatric patients, newborn to 18 years old. The Pivotal Phase III pediatric study data supporting the approval were recently published in Burns, the peer-reviewed journal of the International Society for Burns Injuries. Another potential indication expansion emerged during the Israeli Hamas war, where dozens of patients with blast injuries were treated with Nexobrit. The outcomes were remarkable, and the data from these cases will be presented at the upcoming American Burn Association Conference. Additionally, we reported a positive result from the Expanded Access Protocol, NEXT, which evaluated 239 patients across 29 U.S. burn centers. The study confirmed NEXT's safety and efficacy in eschar removal, as well as its significant reduction in the need for surgical procedures for burn patients. Operationally, we successfully completed the construction of our state-of-the-art GMP manufacturing facility, which remains on track to reach full operational capacity by late 2025. Commercial availability will depend on regulatory approvals from FDA EMA, which are expected in 2026. This facility will significantly expand our production capabilities, allowing us to meet the growing demand the growing global demand, and sustain long-term revenue growth. This year, we also strengthened our balance sheet with a strategic $25 million pipe financing round led by Molniki. This reflects industry confidence in our strategy and provides additional resources to execute our clinical and commercial growth plans. With a robust cash runway of approximately $44 million, MediOne is well positioned to deliver on its critical, clinical, operational, and commercial objectives. Now I'd like to turn the call over to Hani to review our financial performance in greater detail.