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]

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]

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]

Company Overview - Vericel Corporation is a leader in advanced therapies for the sports medicine and severe burn care markets, combining innovations in biology with medical technologies to create a differentiated portfolio of cell therapies and specialty biologics [2] - The company markets three main products in the United States: MACI, Epicel, and holds an exclusive license for NexoBrid [2] Product Details - MACI is an autologous cellularized scaffold product for repairing symptomatic, full-thickness cartilage defects of the knee in adults [2] - Epicel is a permanent skin replacement for treating patients with deep dermal or full-thickness burns covering 30% or more of total body surface area [2] - NexoBrid is a biological orphan product indicated for eschar removal in patients with deep partial-thickness and/or full-thickness thermal burns [2] Upcoming Events - Vericel Corporation will participate in a fireside chat at the Stephens Annual Investment Conference on November 20, 2025, at 11:00 a.m. ET [1]

Financial Data and Key Metrics Changes - The company reported record total revenue of $67.5 million for Q3 2025, exceeding guidance, with MACI revenue growing 25% to $55.7 million [11][12] - GAAP net income was over $5 million, and adjusted EBITDA margin reached 25%, reflecting a nearly 800 basis points increase year-over-year [3][12] - Operating cash flow for the quarter was a record $22.1 million, contributing to a free cash flow of nearly $20 million [12] Business Line Data and Key Metrics Changes - MACI revenue growth was driven by strong biopsy growth, with record highs in both MACI biopsies and the number of surgeons taking biopsies [4][5] - Burn care revenue was $11.8 million, a 21% sequential increase, with EPICEL revenue at $10.4 million, marking its highest quarter of the year [11][12] - NexoBrid revenue reached $1.5 million, its highest since launch, growing 38% year-over-year [11] Market Data and Key Metrics Changes - The company has over 800 MACI Arthro-trained surgeons, with significant growth in biopsy and implant rates among trained surgeons compared to untrained ones [5][6] - The U.K. is targeted for MACI's international expansion, with plans to submit a marketing application in mid-2026 and a potential launch in the first half of 2027 [8][9] Company Strategy and Development Direction - The company is focused on expanding its MACI Salesforce and investing in sales operations, marketing, and medical functions to enhance operational excellence [10] - A phased approach to MACI's international expansion is being initiated, starting with the U.K. due to favorable market conditions [8][9] - The company plans to initiate a phase 3 MACI Ankle Clinical Study, representing a substantial growth opportunity [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining strong top-line growth and profitability, with expectations for continued revenue growth in 2026 and beyond [16][41] - The company anticipates a significant acceleration in MACI revenue growth from 18% in the first half of the year to approximately 23% in the second half [13][14] - Management highlighted the importance of maintaining a prudent approach to guidance, especially in light of potential variability in the burn care segment [45] Other Important Information - The company achieved a gross profit margin of 73.5%, with expectations for a gross margin of approximately 77% in Q4 [12][15] - The company is not assuming additional NexoBrid revenue related to the BARDA RFP process initiated in August, although there is potential for incremental revenue [14][15] Q&A Session Summary Question: Insights on MACI Arthro contributions in 2026 - Management indicated that they expect high contributions from MACI Arthro but will be prudent in guidance, starting with a baseline of around 20% growth for MACI [20][24] Question: MACI Arthro sales in Q3 and expectations for 2026 - Management clarified that they do not view MACI Arthro as cannibalizing legacy MACI but rather as expanding overall MACI utilization [47][49] Question: Trends in MACI biopsy growth and surgeon adoption - Management noted strong biopsy growth across all surgeon types, with a significant increase in trained surgeons leading to higher implant rates [70][71] Question: R&D spending and expectations for Q4 - Management confirmed total operating expenses of about $50 million for Q4, with increased investments in salesforce expansion and the ankle trial [75][78] Question: Post-surgical pain and recovery times with MACI Arthro - Management highlighted positive early indicators of reduced post-surgical pain and faster recovery times associated with MACI Arthro procedures [78][79]

VERICEL Q3 2025 RESULTS NOVEMBER 6, 2025 Safe Harbor Vericel cautions you that all statements other than statements of historical fact included in this presentation that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to r ...

Core Insights - Vericel Corporation reported record total revenue of $67.5 million for Q3 2025, a 16% increase from $57.9 million in Q3 2024 [5][8] - MACI revenue grew by 25% to $55.7 million, contributing significantly to the overall revenue growth [6][10] - The company achieved a net income of $5.1 million, compared to a net loss of $0.9 million in the same quarter last year [10][11] Financial Highlights - Total net revenue for Q3 2025 was $67.5 million, up from $57.9 million in Q3 2024 [5][8] - MACI net revenue was $55.7 million, with Epicel contributing $10.4 million and NexoBrid $1.5 million [5][6] - Gross margin improved to 73.5%, up from 71.9% in Q3 2024 [6][8] - Non-GAAP adjusted EBITDA increased by 69% to $17.0 million, representing 25% of total revenue [10][22] Business Developments - Over 800 MACI Arthro surgeons have been trained to date, indicating strong market engagement [6][10] - The MACI sales force expansion is on track for completion in Q4 2025, with new hires positioned for 2026 [6][10] - The MACI Ankle™ program is set to initiate clinical studies in Q4 2025 [6][10] Guidance and Outlook - Full-year revenue guidance is set between $272 million and $276 million, with MACI expected to grow in the low 20% range [7][10] - The company reaffirmed a gross margin target of 74% and an adjusted EBITDA margin of 26% for the full year [7][10]

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]