MediWound (NasdaqGM:MDWD) FY Conference Transcript

MediWound FY Conference Summary Company Overview - Company: MediWound (NasdaqGM:MDWD) - Industry: Biologics and Wound Care - Key Products: NexoBrid (approved drug), EscharEx (Phase III asset) [2][3] Core Points and Arguments NexoBrid - Description: FDA-approved drug for burn treatment, commercialized in major markets including the U.S., Europe, and Japan [2] - Efficacy: Removes burn eschar within 4 hours, spares healthy tissue, and significantly reduces the need for surgery [2][5] - Market Validation: Generates revenue and is profitable, with a strong balance sheet supported by a recent $30 million capital raise [3][11] - Manufacturing Expansion: Recently expanded manufacturing facility to meet global demand, expected to alleviate current supply constraints by mid-2026 [10][11] EscharEx - Description: Currently in Phase III trials for chronic wounds, targeting a $2.5 billion U.S. debridement market [3][7] - Efficacy: Acts in days rather than weeks, with a strong safety profile demonstrated in Phase II studies [14][19] - Market Opportunity: Estimated peak sales revenue of approximately $831 million across venous leg ulcers and diabetic foot ulcers [19] - Clinical Trials: Interim Phase III readout expected by late 2026, with a focus on complete debridement and facilitating wound closure [9][16] Financial Position - Cash Reserves: $54 million in cash, no debt, allowing for strategic execution without near-term financing pressure [11] - Government Collaboration: Long-standing collaboration with the U.S. government, which funds a significant portion of operations [11][23] Additional Important Content - Regulatory Inspections: New manufacturing facility requires regulatory inspections for product stability before market deployment, expected to begin mid-2026 [21][30] - BARDA Contract: Anticipated conclusion of the BARDA agreement in Q1 2026, which will support stockpiling and development of room temperature stable indications [23][24] - Market Dynamics: Current enzymatic debridement options are limited, with EscharEx positioned to capture market share from surgical procedures [19][20] - Clinical Trial Design: The Phase III trial involves 216 patients across approximately 40 sites in the U.S. and Europe, with a focus on maintaining high statistical power for success [16][32] Conclusion - MediWound is positioned for significant growth with its validated technology in severe burns and a promising pipeline in chronic wound care. The upcoming regulatory approvals, manufacturing expansions, and clinical trial results are critical for future value creation [20]