MediWound Ltd.

And welcome to Maddie Woon's fourth quarter and year-end 2022 earnings call. Today's conference is being recorded. At this time, I would like to turn the conference over to Monique Goss of LifeSci Advisors. Monique, please, go ahead.

Thank you, Operator, and welcome, everyone. Earlier today, Meadowoon issued a press release announcing financial results for the fourth quarter and year ended December 31st, 2022. You may access that release on the company's website under the Investors tab. With us today are Ofer Gonen, Chief Executive Officer of Meadowoon, and Boaz Gurlevi, Chief Financial Officer. 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 Meadowood'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 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 MetaWound. 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 METAWOON'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 METAWOON and any recording or rebroadcast is expressly prohibited without the written consent of METAWOON. Now I'd like to turn the call over to Ofer Gonen, Chief Executive Officer of METAWOON. Ofer?

Thank you, Monique. Good morning, everyone. It is my pleasure to welcome you to our conference call. I'm excited to be here today to discuss the remarkable company achievements in the fourth quarter and throughout 2022. We have made important achievements in all of our programs, positioning ourselves to become a global biopharmaceutical company. During my eight-month tenure as CEO, our progress has been significant, including the FDA approval of Nexobrid, which is now ready for a commercial launch in the United States with our partner VeriCell. This innovative therapy has the potential to transform treatment of severe burns and become the standard of care in the United States as it is already in Europe. Additionally, we are moving Asterix into phase three study in venous leg alters, demonstrating our commitment to advancing treatments for patients in need. Our success is due in part to our strong financial position fueled by fundraising efforts that have brought in $70 million over the past year from top quality institutional investors. Looking ahead, we are well positioned to take advantage of what we believe will be another excellent year. Our team is fully dedicated to realizing the mission of improving patient outcomes and bringing innovative therapies to the global healthcare market. Now let me discuss NexoBreathe in more detail. We were proud to see NexoBreathe approved by the FDA in December. This achievement is a testament to the hard work and dedication of our team, who left no stone unturned in developing the science, conducting the trials, analyzing the data, completing the BLA, and, of course, putting manufacturing protocols in place. We are confident that NexoBridge has the potential to change the standard of care for burn patients in the United States and around the world, and we are proud to be at the forefront of this revolution. We also know that the data and the rigorous review that supported NexoBridge approval validates our technology platform and will support the regulatory pathway for our pipeline products. We look forward to partnering with VeriCell for the U.S. commercial launch of NexoBridge, which has a market potential of $300 million. VeriCell is actively preparing for the launch in the second quarter with their sales teams, medical training, and educational sessions, and we have seen widespread interest and enthusiasm for NexoBridge from burn centers and other healthcare professionals. We are confident in VeriCell's ability to successfully launch NexoBridge and provide access to burn patients in the United States. Our ongoing NexoBreathe expanded access program has allowed physicians at leading burn centers in the United States to gain important first-hand experience using NexoBreathe. We have successfully treated 206 patients at 26 leading burn centers in the United States, and based on their feedback, We are confident that NexoGrid will be an important part of the standards of care practice. We are also pleased to collaborate with the U.S. Department of Defense for the development of NexoGrid as a non-surgical solution for the treatment of burns in the field, and we look forward to continue promoting this project and will provide additional updates this year. Globally, NexoBridge gained marketing approvals in Japan, India, and Switzerland, and we anticipate commercial launches in these large markets later this year. We also anticipate an approval of the pediatric label expansion in Europe by mid-2023, which will further broaden the market and accelerate NexoBridge revenue growth worldwide. NexoBridge generated $26.5 million in revenue last year, and it will be cash flow positive this year. We expect revenue growth to exceed 50% in 2023 due to the product launches, the global demand, and the pediatric label extension in Europe. To meet the growing demand, we are expanding our manufacturing capabilities by scaling up our facility and adding an additional manufacturing line. We are on track to complete this process. Also, in preparation for our expanding needs, we have made some important additions to our team that includes several talented executives who have experience in building world-class facilities, developing innovative wound care products, and executing on commercial operations. This includes Dr. Rob Snyder, our Chief Medical Officer, Ali Palash, our Chief Operating Officer, Barry Wolfensohn, our Executive Vice President of Strategy and Corporate Development, and Alisa Torinova, our Vice President of European Operations. These talents will be essential for expanding our global presence, supporting the increased demand of exobricks. Accelerate our blockbuster opportunity.