MediWound Ltd.

Good day and welcome to MediWUN's fourth quarter and full year 2023 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 Gaia Shamus 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 fourth quarter and full year ended December 31, 2023. You may access that release on the company website under the Investors tab. With us today are Ofer Gonen, Chief Executive Officer of MediWound, Hani Luxemburg, Chief Financial Officer, and Barry Wolfenson, Executive Vice President of Strategy and Corporate Developments. Following our preferred 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 many ones 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 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 forecasts due to the impact of many factors beyond the control of Medimund. 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 the cautionary notes set forth in today's press release, as well as at-risk factors set forth in MediWound's annual report filed with the SEC for factors that would 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 Yonen, Chief Executive Officer of MediWound.

Ofer? Thank you, Gaia, and good morning, everyone. Welcome to MediWound's fourth quarter and full year 2023 conference call. Joining me today are Hani Luxemburg, our Chief Financial Officer, and Barry Wolfenson, our Executive Vice President of Strategy and Corporate Development. Following our discussion of the financial results and business highlights, we will open the call for questions. I'm excited to share that we had a remarkable year. Our unwavering commitment to executing our commercial strategy of NexoBridge coupled with our substantial operational excellence has yielded revenue of $19 million. Furthermore, we are making significant progress towards initiating our phase three trial of Escorex, a product which targets a $2 billion market. Utilizing the same proven active pharmaceutical ingredient as Nexobrid, Escorex has demonstrated superiority over the current market leader in phase two studies. Let's begin on discussion with the major milestones we have achieved with Nexobrid in 2023. NexoBID had an exciting year on a number of fronts. It generated $19 million in revenue, which was primarily driven by its commercial availability in the United States, Japan, and India. Additionally, it received approval for pediatric use in Europe and is currently under review by the FDA for pediatric use as well. Moreover, NexoBRID continues to benefit from federal funding in the United States, supporting both emergency preparedness and ongoing research and development activities. The demand for NexoBRID currently exceeds our production capabilities. We are actively scaling up our GMP-compliant state-of-the-art facility, which is on schedule for completion by mid-2024. we anticipate achieving full production capacity in 2025. This expansion will enhance our production capabilities six-fold, enabling us to fulfill the increasing global demand for NexoBridge. Now let's discuss each of the drivers for NexoBridge growth in further detail. NexoBridge was introduced to the U.S. market by our partner, VeriCell, at the end of the third quarter. VeriCell is focused on building a strong foundation for NexoBridge by supporting P&T committee approvals. At the end of 2023, more than 50 burn centers submitted packages to their P&T committees, out of which over 25 centers gained committee approvals, and nearly 20 centers placed initial product orders. Most notably, the clinical outcomes and the feedback from burn surgeons regarding the initial patient treated with Nexobrid have been extremely positive. This is a strong indicator of Nexobrid potential to change the standard of care in ESCA removal for patients with severe burns. As for commercial access, CMS granted Nexobrid a permanent J-code and transitional pass-through payment status. This became effective in January 2024. NexoBridge has also successfully launched in two major markets, Japan through our partnership with Kaiken Pharmaceuticals and in India through BSV. Both launches have been progressing as planned and have generated further demand for NexoBridge. In Europe, we expanded our commercial activity by establishing a collaboration with Polymedics, which will further facilitate greater NexoBrit usage in Germany, Austria, Belgium, the Netherlands, and Luxembourg. The transformative potential of NexoBrit as the new standard of treating of severe burns in emergency scenarios was highlighted during the war in Israel. Last October, we allocated our entire non-US NexoBridge inventory to meet the critical demand for treating mass casualty burn incidents. NexoBridge paved instrumental in saving lives across both military and civilian sectors. This successful development has sparked increased interest from various global governments in stockpiling NexoBridge for future emergencies. Our partnership with the U.S. government remains solid. We have secured $13 million RMT grant from the U.S. Department of Defense to develop and to manufacture a new formulation for NexoBread that is stable at room temperature. This innovation is intended for the U.S. Army as a non-surgical treatment for traumatic burns on the battlefield. Additionally, We have received an extra $10 million from BARDA. This funding is designated for the replenishment of expired product previously procured for emergency readiness, along with supporting further R&D efforts. We have also received European Commission approval to broaden NexoBridge's label in Europe to include patients for all ages. Additionally, a supplemental BLA for pediatric use has been accepted for review by the FDA with a decision anticipated later this year. Considering the pediatric patients, consider that those patients represent approximately 40% of all burn victims, this approval could substantially expand Nexobrid market reach. Overall, we are very pleased with the tremendous progress we have made with Nexobrid this year. and the strong global demand we have experienced. As we enter 2024, the influx of order for the entire year has allowed us to project revenues of $24 million. Looking ahead, we anticipate significant revenue growth exceeding 40% in the coming years, with revenue projection of $30 million for 2025 and $39 million for 2026. Now I would like to discuss escarex. We are fully aligned with both FDA and EMA on the phase three protocol, evaluating escarex in patients with venous leg ulcers. The protocol submission is planned for the first half of this year, and we anticipate initiating the trial in the second half of 2024. This will be a multicenter, prospective, randomized, and placebo-controlled global trial. We aim to enroll 216 patients in over 40 sites that will be randomized one-to-one to receive either escarex or placebo. The trial will focus on two co-primary endpoints, the incidence of complete debridement and the indication of the incidence of wound closure. An interim assessment is scheduled after 67% of the patients have completed the trial. The study is estimated to take about 24 months to complete. The design of the trial is very similar to our successful Phase II studies, and the chosen sample size provides 90% statistical power. We were excited to recently report the results of a head-to-head comparative analysis of escarex versus SANTIV. And now I will hand it over to Barry, who will elaborate further. Barry?