MediWound Ltd.

Good day, and welcome to MediWoon's second quarter 2023 earnings call. Today's conference is being recorded. At this time, I would like to turn the conference over to Monique Cossie of Lifesize Advisors. Please go ahead.

Thank you, Operator, and welcome, everyone. Yesterday, after the market closed, MediWoon issued a press release announcing financial results for the second quarter ended June 30, 2023. You may access that release on the company's website under the Investors tab. With us today are Ofra Gonen, Chief Executive Officer of Mediwound, Hani 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 including the Q&A session relating to MediWomb'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 forecasts due to the impact of many factors beyond the control of METALU. 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 MediWood'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. The conference call is the property of MediWood and any recording or rebroadcast is expressly prohibited without the written consent of MediWood. Now I would like to turn the call over to Ofer Gonan, Chief Executive Officer of MediWood. Ofer?

Thank you, Monique, and good morning, everyone. By the way, this call is not recorded, although the operator said so, so I'm live. It's a pleasure to welcome all of you to the second quarter earnings conference call. Joining me today are Hani Luxemburg, our chief financial officer, and Barry Wolfenson, our executive vice president of strategy and corporate development. After our prepared remarks, we will open the call for a Q&A session. I'd like to begin with a comprehensive overview of MediWound's recent progress. We are focused on advancing our commercial product portfolio, expanding our pipeline, strengthening our strategic partnership, building new alliances, and expanding our manufacturing capabilities. With a solid financial foundation, we are well positioned to achieve our goals and ultimately become a profitable global biopharmaceutical company. Let's start with a more detailed update on NexoBridge. We received approval in the United States last December. Since the achievement of this important milestone, we have focused on manufacturing and delivering products to our partner VeriCell for their U.S. commercial launch. We shipped NexoBri to VeriCell in June 2023. However, at this time, VeriCell is unable to release the product for commercial distribution due to a deviation associated with a third-party testing lab used during the manufacturing process. We have conducted extensive testing and completed a detailed risk assessment, determining that this deviation presents no incremental risk to finished product quality and for patient safety. Vericel and MediWound continue to engage constructively with the FDA concerning NexoBread, and we remain hopeful that the product will be commercially available in the United States in the near term. VeriCell has guided its NexoBrit commercial launch in the United States market to the first quarter of 2024. This timing will not affect our expected NexoBrit revenues in 2023 and 2024, as there are multiple other partners to whom we can sell the inventory. In the meantime, we are in the process of manufacturing the next batches of NexoBrit for delivery to VeriCell. These batches will not be impacted by this variation. Pre-launch activities remain on track and VeriCell team has generated significant interest and enthusiasm for NexoBreathe in the burn care community. Additionally, we are on track to submit our SPLA for the pediatric indication in the second half of 2023. Our relationship with BARDA remains strong as we are awarded with additional $10 million in funding to support the $3 million replenishment, the SPLA submission for the pediatric indication, and the enrollment of an additional 50 patients into our next program. To date, 237 burn patients have been treated across 26 sites in the United States in this expanded access program. Moving to the rest of the world, in Japan, Kaken Pharmaceutical has successfully launched NexoBrick commercially. Kaken is a notable pharmaceutical company and holds an exclusive partnership with us. The Japanese market is very substantial, with over 6,000 patients annually receiving treatment for severe burns. A majority of these patients undergo ESCA removal as a crucial initial step. Notably, Japan is the first territory where NexoBREAD is approved for both adults and pediatric patients. In Europe, we continue to see the demand for NexoBREAD escalate as it is adopted more broadly. We are also awaiting a decision for the European Commission on Pediatric Indication, which we anticipate in the second half of this year. In response to the increasing demand of NexoBREED and the upcoming products, we have finalized a long-term lease for the production sites. This guarantees continuous manufacturing of NexoBREED and S-Corex. We have also initiated a project to expand our current facility to accommodate the rising global need of NexoBREED. We anticipate completing the expansion of this facility by mid-2024 and reaching full manufacturing capacity in 2025. Moving now to our SCRx program, we are gearing up for the launch of our Phase III study, focusing on venous leg ulcers. Our carefully structural trial adopted a multicenter, prospective, randomized, and placebo-controlled methodology to rigorously evaluate escarex's potential. The study aims to enroll 244 patients who will be equally distributed between escarex and placebo treatments. Given the study's manageable size and the lack of a direct competition, we are optimistic about expedited patient enrollment. Encouraging feedback from both Emma and the FDA has solidified our confidence in SCRx's global approval trajectory. We are in the process of qualifying the study sites, selecting all the vendors, including CRO, data management, and central labs. And of course, we are manufacturing the final batches of SCRx for the clinical study. These activities are expected to be completed by the fourth quarter of 2023, with patient enrollment in the phase three study expected to begin in early 2024. Furthermore, ESCAROTES has been a focal point of interest among potential partners in the advanced wound care domain who are interested in game-changing modalities. The fact that the largest players in the market today are eager to take part in this venture is yet another indication for the great promise of our study. I would like to hand over the call to Barry, who will provide more color around our strategic opportunities, including two announcements that we made just yesterday. Barry?