MediWound (NasdaqGM:MDWD) Q3 2025 Earnings Call November 20, 2025 08:30 AM ET Company ParticipantsBarry Wolfenson - EVP of Strategy and Corporate DevelopmentOfer Gonen - CEODan Ferry - Head of Investor RelationsHani Luxenburg - CFOConference Call ParticipantsMichael Okunewitch - AnalystJosh Jennings - AnalystNone - AnalystJeff Jones - AnalystOperatorGood morning, everyone, and welcome to the MediWound's third quarter 2025 earnings call. All participants will be in a listen-only mode. Should you need assista ...

MediWound (NasdaqGM:MDWD) Q3 2025 Earnings Call November 20, 2025 08:30 AM ET Company ParticipantsBarry Wolfenson - EVP of Strategy and Corporate DevelopmentOfer Gonen - CEODan Ferry - Head of Investor RelationsHani Luxenburg - CFOConference Call ParticipantsMichael Okunewitch - AnalystJosh Jennings - AnalystNone - AnalystJeff Jones - AnalystOperatorGood morning, everyone, and welcome to the MediWound's third quarter 2025 earnings call. All participants will be in a listen-only mode. Should you need assista ...

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]

MediWound (MDWD) came out with a quarterly loss of $0.24 per share versus the Zacks Consensus Estimate of a loss of $0.81. This compares to a loss of $0.98 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +70.37%. A quarter ago, it was expected that this developer of treatments for burns and hard-to-heal wounds would post a loss of $0.55 per share when it actually produced a loss of $1.23, delivering a surprise of -123.64%.Over ...

Ongoing Enrollment Continues in VALUE Phase III Trial of EscharEx® in Venous Leg Ulcers Commissioning Completed for Expanded NexoBrid® Facility; Full Operational Capacity Expected by Year-End 2025 Balance Sheet Strengthened with $30 Million Equity Financing Third Quarter 2025 Revenue of $5.4 Million, Up 23% Year-over-Year Conference Call Today, November 20, 2025, at 8:30 a.m. Eastern Time YAVNE, Israel, Nov. 20, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzy ...

MediWound to Report Third Quarter 2025 Financial Results Conference call and webcast scheduled for Thursday, November 20 at 8:30 a.m. Eastern Time YAVNE, Israel, November 5, 2025 -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced that it will release its financial results for the third quarter ended September 30, 2025 on Thursday, November 20, 2025. Following the release, the Company’s management will host a confere ...

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].

Core Insights - MediWound has received marketing authorization for NexoBrid from Australia's Therapeutic Goods Administration (TGA), allowing its use for both adults and children with deep partial- and full-thickness thermal burns [1][2] - NexoBrid is now authorized in 45 countries, establishing it as a new standard of care in burn management, with a commercial launch expected in Australia in Q4 2025 [2][3] - The company is expanding its manufacturing capabilities, which are on track for completion by the end of 2025, to meet global demand for NexoBrid [2][3] Product Overview - NexoBrid is a topically administered biological orphan drug designed for the enzymatic removal of eschar in patients with deep partial- and full-thickness thermal burns, preserving viable tissue while removing non-viable tissue [4] - The product is already approved in over 40 countries, including the United States, European Union, and Japan [4][5] Company Background - MediWound Ltd. is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair, with NexoBrid being its FDA-approved product [5] - The company is also advancing EscharEx, a late-stage investigational therapy for chronic wound debridement, which has shown clinical advantages over leading products in the market [5] Market Expansion - The TGA approval of NexoBrid is seen as a significant step in improving access to innovative burn care solutions in Australia and opens opportunities for expansion into the broader Asia-Pacific region [3] - Balance Medical, MediWound's exclusive partner in Australia, is expected to initiate the commercial launch of NexoBrid in the fourth quarter of 2025 [2][3]