MediWound(US:MDWD)2025-11-20 14:32Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $5.4 million, a 23% increase year-over-year from $4.4 million in Q3 2024 [11] - Gross profit for the quarter was $0.9 million, or 16.5% of revenue, compared to $0.7 million, or 15.5% in the prior year [11] - Net loss was $2.7 million, or $0.24 per share, compared to a net loss of $10.3 million, or $0.98 per share in the prior year [13] - Cash position as of September 30, 2025, was $60 million, up from $44 million at year-end 2024 [15] Business Line Data and Key Metrics Changes - EscharEx's VALUE Phase III trial for venous leg ulcers is progressing with a target of 216 patients across approximately 40 sites [4] - NexoBrid's manufacturing facility expansion has increased production capacity sixfold, with full operational capacity expected by year-end 2025 [8] - NexoBrid reported record quarterly revenue growth of 38% year-over-year and 26% sequentially [8] Market Data and Key Metrics Changes - Medicare's recent reduction in reimbursement rates for skin substitute products is expected to pressure that category, making EscharEx more attractive as it is regulated under the BLA pathway [7] - The updated U.S. market access assessment estimates annual peak sales for EscharEx at about $831 million, reflecting robust clinical data and health economic benefits [7] Company Strategy and Development Direction - The company is focused on three strategic priorities: advancing the EscharEx trial, expanding NexoBrid manufacturing, and securing funding for its strategy [4] - The company aims to leverage market changes to position EscharEx as a leading product in the enzymatic debridement segment [7] - The collaboration with BARDA is expected to resume following the government shutdown, which will support the development of NexoBrid [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning for growth in 2026, citing consistent execution and strategic progress [16] - The company is actively monitoring enrollment trends in clinical trials and will update guidance as visibility improves [5] Other Important Information - The company completed a $30 million equity financing, enhancing its financial flexibility to execute long-term growth strategies [10] - The TGA in Australia approved NexoBrid for use in both adult and pediatric patients, expanding its global presence [9] Q&A Session Summary Question: Changes in peak sales assumptions for EscharEx - Management clarified that the increase in peak sales estimate to $831 million is primarily due to updated pricing assumptions based on market access analysis, with no changes in patient volume or adoption rates [25] Question: Breakdown of revenue sources - Management indicated that detailed revenue breakdowns are not provided in quarterly reports, but gross margin improvements reflect a favorable revenue mix [44] Question: Status of BARDA contract - The BARDA contract has not yet been awarded, but the company is awaiting the signing of the proposal submitted for a 10-year contract [46] Question: Impact of CPT code on adoption - Management noted that while a temporary CPT code is in place, a permanent code would enhance legitimacy and drive physician and institutional adoption of NexoBrid [39]