MediWound Reports New Clinical Data Demonstrating NexoBrid®’s Effectiveness in Preventing Traumatic Tattoos After Abrasion and Blast Injuries Prospective clinical data show NexoBrid® removes embedded particles in friction and blast wounds, reducing pigmented wound surface by >90% Traumatic tattoos form when dirt, metal, or explosive residue becomes permanently embedded in the skin; findings support further evaluation in acute trauma settings YAVNE, Israel, December 10, 2025 -- MediWound Ltd. (Nasdaq: MDWD ...

Financial 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, primarily driven by higher development services revenue [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, an improvement from 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 enrollment of 216 patients across approximately 40 sites [4] - NexoBrid's manufacturing facility expansion has increased production capacity sixfold, with expectations to reach full operational capacity by year-end 2025 [8] - NexoBrid reported record quarterly revenue growth of 38% year-over-year and 26% sequentially in the U.S. [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] - An updated market 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] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategic progress and operational readiness, positioning MediWound for growth in 2026 [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 collaboration with BARDA on stockpiling and development activities is expected to resume following the end of a government shutdown [9] Q&A Session Summary Question: Changes in peak sales assumptions for SCAR-EX - 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 [23][25] Question: Breakdown of revenue sources - Management indicated that detailed revenue breakdowns are not provided in quarterly calls, but gross margin improvements reflect a favorable revenue mix [44] Question: Update on BARDA contract status - The BARDA contract has not yet been awarded, but a proposal has been submitted, and the company is awaiting contract signing [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 adoption and institutional acceptance [39]

Financial 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]

Financial 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, primarily driven by higher development services revenue [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 for Q3 2025 was $2.7 million, or $0.24 per share, an improvement from a net loss of $10.3 million, or $0.98 per share in Q3 2024 [12] - Adjusted EBITDA loss was $5.4 million, compared to a loss of $3.7 million in Q3 2024 [12] - As of September 30, 2025, cash and cash equivalents were $60 million, up from $44 million at year-end 2024 [15] Business Line Data and Key Metrics Changes - The EscharEx VALUE phase III trial for venous leg ulcers (VLU) is progressing with a target enrollment of 216 patients across approximately 40 sites [4] - NexoBrid manufacturing capacity has expanded 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 in the U.S. [8] Market Data and Key Metrics Changes - Medicare's recent reduction in reimbursement rates for skin substitute products is expected to pressure that category, while EscharEx aims to enter a market with a single legacy product generating approximately $370 million annually [6] - Updated U.S. market access and pricing 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 an attractive option for strategic partners [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of clinical trials and the potential for EscharEx to drive growth [4] - The company is actively monitoring enrollment trends in the VALUE trial and will update guidance as visibility improves [5] - The recent $30 million equity financing strengthens the balance sheet and provides resources for long-term growth [10] Other Important Information - The company has received positive FDA feedback for its diabetic foot ulcer program and plans to initiate the study in the second half of 2026 [5] - The collaboration with BARDA on stockpiling and development activities is expected to resume following the end of the government shutdown [10] Q&A Session Summary Question: Can you provide details on the new peak sales assumption for SCAR-EX? - The updated U.S. peak sales estimate of $831 million reflects a focus on pricing rather than changes in patient volume or adoption rates [22][24] Question: What is the breakdown between DFU and VLU opportunities in the sales projection? - There are more diabetic foot ulcers than venous leg ulcers, but the company is prioritizing VLU due to pain issues associated with surgical debridement [30][32] Question: What is the status of the BARDA contract? - The BARDA RFP for a 10-year contract is pending, and the company is awaiting the contract to be signed [44] Question: How does the lack of a permanent CPT code impact adoption? - A permanent CPT code would enhance legitimacy and drive physician and institutional acceptance, facilitating wider adoption of NexoBrid [36][39]

Core Insights - MediWound reported a quarterly loss of $0.24 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.81, representing an earnings surprise of +70.37% [1] - The company posted revenues of $5.43 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 15.52%, but showing an increase from $4.36 million year-over-year [2] - MediWound has surpassed consensus EPS estimates three times over the last four quarters and topped consensus revenue estimates two times in the same period [2] Financial Performance - The company experienced a loss of $0.98 per share in the same quarter last year, indicating improvement in financial performance [1] - The current consensus EPS estimate for the upcoming quarter is -$0.85 on revenues of $7.7 million, and for the current fiscal year, it is -$2.69 on revenues of $23.79 million [7] Market Position - MediWound shares have increased by approximately 0.3% since the beginning of the year, underperforming compared to the S&P 500's gain of 12.9% [3] - The Zacks Industry Rank for Medical - Drugs is in the top 29% of over 250 Zacks industries, indicating a favorable industry outlook [8] Future Outlook - The sustainability of MediWound's stock price movement will depend on management's commentary during the earnings call and future earnings expectations [3][4] - The estimate revisions trend for MediWound was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, suggesting it is expected to perform in line with the market [6]

Core Insights - MediWound Ltd. reported a third quarter 2025 revenue of $5.4 million, representing a 23% increase year-over-year from $4.4 million in Q3 2024 [6][25] - The company completed the commissioning of its expanded NexoBrid manufacturing facility, which is expected to reach full operational capacity by the end of 2025, increasing production capacity sixfold [2][7] - Enrollment in the VALUE Phase III trial of EscharEx for venous leg ulcers is ongoing, targeting 216 patients across approximately 40 sites in the U.S. and Europe [7] Financial Performance - The gross profit for Q3 2025 was $0.9 million, or 16.5% of total revenue, compared to $0.7 million, or 15.5% of total revenue in Q3 2024 [13][25] - Research and development expenses increased to $3.5 million in Q3 2025 from $2.5 million in Q3 2024, driven by investments in the EscharEx VALUE Phase III trial [13] - The net loss for Q3 2025 was $2.7 million, or $0.24 per share, a significant reduction from a net loss of $10.3 million, or $0.98 per share, in Q3 2024 [13][25] Corporate Developments - The company raised $30 million in equity financing to strengthen its balance sheet and support development programs and commercialization initiatives [5][9] - An independent global consulting firm estimated a peak sales opportunity of approximately $831 million for EscharEx, reflecting updated clinical data and health-economic considerations [7] - NexoBrid received approval for use in Australia, expanding its market presence to 45 countries worldwide [7] Upcoming Milestones - A pre-specified interim sample-size assessment for the VALUE Phase III trial is planned after 65% of patients complete treatment [7] - The company expects to initiate its clinical trial in diabetic foot ulcers in the second half of 2026 following positive FDA feedback [7]

Core Viewpoint - MediWound Ltd. is set to release its financial results for the third quarter of 2025 on November 20, 2025, and will host a conference call to discuss these results and provide a corporate update [1][2]. Company Overview - MediWound Ltd. is a global biotechnology company specializing in enzymatic therapies for non-surgical tissue repair. The company’s FDA-approved product, NexoBrid, is used for the enzymatic removal of eschar in thermal burns and is marketed in multiple regions including the U.S., European Union, and Japan [3]. - The company is also advancing EscharEx, a late-stage investigational therapy aimed at the debridement of chronic wounds, which has shown clinical advantages over existing products and targets a significant global market opportunity [3].

Core Insights - MediWound Ltd. has successfully completed the commissioning of its expanded GMP manufacturing facility in Yavne, Israel, which is a significant step towards increasing production capacity for NexoBrid® by approximately sixfold by the end of 2025 [1][2] Company Overview - MediWound Ltd. is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair, with its FDA-approved product NexoBrid® indicated for the enzymatic removal of eschar in thermal burns [4] - NexoBrid® is approved for use in over 40 countries, including the United States, European Union, and Japan, and is designed to selectively remove non-viable tissue while preserving viable tissue [3] Manufacturing and Supply Capacity - The newly expanded facility will enable a scalable and reliable global supply of NexoBrid across more than 40 approved markets, contingent upon the completion of regulatory reviews [2] - The operational readiness of the expanded facility is expected by year-end 2025, which will help meet the growing global demand for NexoBrid [2][4]

Core Points - MediWound has entered into a definitive securities purchase agreement for the sale of 1,734,105 ordinary shares at a price of $17.30 per share, aiming to raise approximately $30 million in gross proceeds [1] - The offering is expected to close around September 30, 2025, pending customary closing conditions [1] - The net proceeds will primarily support EscharEx's pre-commercial activities, enhance manufacturing capabilities, and cover general corporate purposes [1] - H.C. Wainwright & Co. is the exclusive placement agent for this offering [1]

Core Viewpoint - MediWound Ltd. has announced a registered direct offering of ordinary shares, aiming to raise approximately $30 million to support its pre-commercial activities for EscharEx and enhance manufacturing capabilities [1][2]. Group 1: Offering Details - The company will sell 1,734,105 ordinary shares at a price of $17.30 per share, with the offering expected to close around September 30, 2025, pending customary closing conditions [1]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering [2]. - The gross proceeds from the offering are anticipated to be about $30 million before deducting fees and expenses [2]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be used to support EscharEx's pre-commercial activities, enhance large-scale manufacturing capabilities, and for general corporate purposes [2]. Group 3: Company Overview - MediWound Ltd. is a biotechnology company focused on developing enzymatic therapies for non-surgical tissue repair, with its FDA-approved product NexoBrid for thermal burns [5]. - The company is advancing EscharEx, a late-stage investigational therapy for chronic wound debridement, which has shown clinical advantages over leading products in the market [5].