MediWound Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

Core Insights - MediWound Ltd. has initiated the VALUE Phase III pivotal trial for EscharEx® targeting venous leg ulcers, marking a significant milestone in its clinical development [1][3][6] - The company reported a revenue of $20.2 million for the full year 2024, an increase from$18.7 million in 2023, driven by new contracts and increased sales [10][13] - MediWound has expanded strategic collaborations with industry leaders, including Kerecis, to enhance its research capabilities and improve patient outcomes [1][3][6] Financial Performance - Fourth quarter revenue was $5.8 million, compared to$5.3 million in the same quarter of 2023, reflecting a growth of approximately 9.4% [13] - The gross profit for the fourth quarter was $0.9 million, with a gross margin of 15.5$0.7 million and a 13.5% gross margin in the prior year [13] - The net loss for 2024 was $30.2 million, or$3.03 per share, compared to a net loss of $6.7 million, or$0.75 per share in 2023, primarily due to financial expenses related to warrant revaluation [10][13] Clinical Developments - The VALUE Phase III trial will enroll 216 patients across 40 sites in the U.S. and Europe, with an interim analysis expected in mid-2026 [6] - A Phase II study protocol has been submitted to the FDA for a head-to-head trial comparing EscharEx to collagenase in VLU patients, aimed at supporting a future Biologics License Application [6] - NexoBrid, another product from MediWound, has seen a 42% increase in hospital orders in the fourth quarter compared to the previous quarter, indicating strong market adoption [6][10] Strategic Collaborations - MediWound has secured €16.5 million in funding from the European Innovation Council to accelerate EscharEx's development for diabetic foot ulcers, with a Phase II/III trial expected to start in 2026 [6] - The company has completed a comparative analysis of EscharEx against SANTYL®, demonstrating superior clinical outcomes for EscharEx [6] - The collaboration with Mölnlycke Health Care, which led a $25 million private investment, further strengthens MediWound's position in the wound care market [8] Market Potential - The total addressable market for EscharEx in the U.S. is estimated at$2.5 billion, with a projected market share of 22% upon approval, leading to peak sales expectations of approximately $725 million [6] - The company is advancing its manufacturing capabilities with a new GMP-compliant facility expected to increase output sixfold by the end of 2025 [6] Cash Position - As of December 31, 2024, MediWound had cash and cash equivalents totaling$43.6 million, an increase from $42.1 million in 2023 [11] - The company raised$25 million through a PIPE offering and received additional funding from various sources, including grants and warrant exercises [11][13]