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]

MediWound to Report Fourth Quarter and Full Year 2025 Financial Results Conference Call and Webcast Scheduled for Thursday, March 5th at 8:30 a.m. Eastern Time YAVNE, Israel, February 19, 2026 -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2025 on Thursday, March 5, 2026. Following the release, MediWound’s management will host a con ...

Core Viewpoint - MediWound Ltd. is actively engaging with investors by presenting at two upcoming healthcare conferences, showcasing its advancements in enzymatic therapeutics for tissue repair [2]. Group 1: Upcoming Conferences - MediWound will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026, at 10:40 a.m. ET, in a virtual format [2]. - The company will also participate in the TD Cowen 46th Annual Health Care Conference on March 2, 2026, at 1:10 p.m. ET, held at the Boston Marriott Copley Place, Boston, MA [2]. - Live webcasts of both presentations will be available through the conference websites and on MediWound's Investor Relations section [2]. Group 2: Company Overview - MediWound Ltd. is a global biotechnology company specializing in enzymatic, non-surgical therapies for tissue repair [3]. - The company's FDA-approved product, NexoBrid, is designed for the removal of eschar in thermal burns and is marketed in the United States, European Union, Japan, and other international markets [3]. - MediWound's late-stage pipeline product, EscharEx, is an investigational therapy aimed at the debridement of chronic wounds, with the potential to establish a new standard of care in wound management [3].

Core Insights - MediWound Ltd. provided a corporate and financial update ahead of the J.P. Morgan Healthcare Conference, highlighting progress in its clinical pipeline and operational capabilities [1][2] Corporate Updates - The EscharEx VALUE Phase III trial for venous leg ulcers (VLUs) is ongoing, with an interim assessment and enrollment completion expected by year-end 2026 [1][6] - Plans to expand the EscharEx program to diabetic foot ulcers (DFUs) and pressure ulcers (PUs) are anticipated in 2026 [1][6] - The NexoBrid manufacturing facility has been expanded and is now fully operational, increasing production capacity sixfold [1][6] Financial Outlook - Revenue for the full year 2025 totaled $17 million [5] - Updated financial guidance projects revenues of $24–26 million for 2026, $32–35 million for 2027, and $50–55 million for 2028 [1][12] - The company reported a cash position of $54 million as of December 31, 2025, with no debt [12]

Core Insights - MediWound Ltd. announced new clinical data demonstrating that NexoBrid effectively reduces embedded particles in traumatic tattoos caused by abrasion and blast injuries, achieving over 90% reduction in pigmented wound surface [1][4] Clinical Study Findings - The study published in the Journal of Burn Care & Research involved 15 patients with traumatic tattoos, showing a mean pigmented wound area decrease from 37.5% to 2.1% after NexoBrid application, indicating a 92.5% reduction [3][4] - In abrasive injuries, an average of 96% of visible pigments were removed, while in explosive injuries, pigment load was reduced by 84% [4] - The treatment was well tolerated, performed at bedside, with no treatment-related adverse events reported [4] Mechanism and Application - NexoBrid utilizes selective enzymatic action to remove non-viable tissue while preserving viable tissue, providing precision in treating irregular wound depths from blast injuries [5][9] - The application involves a 1–3 mm layer of NexoBrid under occlusion for four hours, followed by gentle scrubbing to reveal a clean wound bed [6] Limitations and Future Research - The study acknowledges limitations such as small sample size and short follow-up, suggesting the need for larger controlled studies to confirm long-term cosmetic outcomes [8] Company Overview - MediWound is a biotechnology company specializing in enzymatic, non-surgical therapies for tissue repair, with NexoBrid approved in over 40 countries for the treatment of thermal burns [11]

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]