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]

Financial Data and Key Metrics Changes - The company reported a compounded annual revenue growth rate of around 20% since the launch of MACI in 2017, leading to impressive margin expansion with gross margins at approximately 73% and adjusted EBITDA margins at 23% last year [7][8] - The company has been profitable every quarter for the past five years, with positive operating cash flow, and ended the second quarter with about $165 million in cash and no debt [8][9] Business Line Data and Key Metrics Changes - MACI has become the leading restorative cartilage repair product, with significant market penetration in patella and larger defects, while MACI Arthro targets smaller defects, representing a substantial market opportunity [11][12] - The burn care segment includes two products: Epicel, which has been marketed for over 10 years, and NexoBrid, launched recently, with Epicel revenue up 16% last year [33][34] Market Data and Key Metrics Changes - The addressable market for MACI is characterized as approximately 60,000 patients annually, with significant opportunities in smaller defects and a targeted surgeon community of about 5,000 [11][12][14] - The burn care market is smaller, with about 40,000 hospitalized burn patients each year, and NexoBrid is expected to provide a more predictable revenue stream as it targets a larger patient base [37][38] Company Strategy and Development Direction - The company aims to expand its product portfolio with MACI Ankle, which could increase the overall MACI addressable market to over $4 billion, with a potential launch around 2031 [48][49] - International expansion is planned for 2027 or 2028, with a roadmap expected by the end of this year [43][44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential of MACI Arthro and its ability to penetrate the market further, while also highlighting the unique revenue growth and profitability profile of the company [54] - The company anticipates a significant inflection in cash flow generation moving forward, supported by recent investments and operational efficiencies [52][54] Other Important Information - The company is expanding its sales force in anticipation of increased demand, particularly in the fourth quarter, and expects to have these positions filled soon [27][28] - The BARDA RFP for NexoBrid is in progress, with proposals submitted and expected outcomes aligned with national security preparedness [40][41] Q&A Session Summary Question: What is the market expansion opportunity for MACI Arthro? - The addressable market for MACI is about 60,000 patients annually, with MACI Arthro targeting smaller defects, representing a significant growth opportunity [11][12] Question: How is the surgeon training for MACI Arthro progressing? - About one-third of trained surgeons are new MACI users, with a good mix of existing and new users being trained [16][19] Question: What is the outlook for the burn care division? - Epicel is expected to continue growing, while NexoBrid is anticipated to provide a more predictable revenue stream as it targets a larger patient base [33][34][38] Question: What is the capital allocation strategy moving forward? - The company plans to invest in sales force expansion and product development while remaining selective in business development opportunities [52][53]

Core Insights - MediWound's NexoBrid will be featured in 36 scientific presentations at the 21st European Burns Association Congress, emphasizing its significance in burn care advancements [1][2][3] Group 1: NexoBrid's Clinical Impact - Presentations will showcase data on pediatric, elderly, and critically burned patients, demonstrating consistent benefits in survival, recovery, and scar outcomes, as well as its effectiveness in infection control and modulation of systemic inflammatory responses [2] - Comparative and long-term studies support NexoBrid's superiority over surgical excision, reinforcing its role in routine care and mass casualty scenarios [2] Group 2: Company Overview - 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 biologic for the enzymatic removal of eschar in thermal burns [6] - The company is also advancing EscharEx, a late-stage investigational therapy for chronic wound debridement, which has shown clinical advantages over leading products [6] Group 3: Support and Funding - NexoBrid's development has received federal funding from the U.S. Department of Health and Human Services and BARDA, supporting pivotal clinical studies and the marketing approval process [5]

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 full-thickness cartilage defects in the knee, applicable to 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 burns [2] Upcoming Events - Vericel Corporation will participate in a fireside chat at the Wells Fargo Healthcare Conference on September 4, 2025, at 3:45 p.m. ET, with a webcast available on their Investor Relations website [1]

Core Insights - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics for tissue repair, with a focus on developing and commercializing enzymatic therapies for non-surgical tissue repair [3]. Company Overview - MediWound's FDA-approved product, NexoBrid, is designed for the enzymatic removal of eschar in thermal burns and is marketed in the U.S., European Union, Japan, and other international markets [3]. - The company is advancing EscharEx, a late-stage investigational therapy for the debridement of chronic wounds, which has shown clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity [3]. Upcoming Events - Ofer Gonen, the CEO of MediWound, will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 4:30 p.m. ET [1]. - A live webcast of the event will be available on MediWound's website [2].

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $5.7 million, up from $5.1 million in Q2 2024, reflecting a 43% sequential growth and an increase year over year [10] - Gross profit for the quarter was $1.3 million, representing 23.5% of revenue, compared to $400,000 or 8.8% in the prior year period, indicating a significant margin increase [11] - Net loss for Q2 2025 was $13.3 million or $1.23 per share, compared to a net loss of $6.3 million or $0.68 per share in the same period last year [12] Business Line Data and Key Metrics Changes - NexoBrid reported a 52% year-over-year revenue growth in Q2 2025, driven by increases in hospital unit orders and the number of ordering centers [8] - Research and development expenses rose to $3.5 million in Q2 2025 from $1.9 million in Q2 2024, primarily due to investments in the EscharEx VALUE Phase III study [11] Market Data and Key Metrics Changes - The EscharEx VALUE Phase III trial is actively enrolling patients, aiming to enroll 216 patients across 40 sites in the U.S. and Europe [5] - The commissioning of the new manufacturing facility is on track for completion by year-end 2025, which is critical for supporting global growth [9] Company Strategy and Development Direction - The company remains focused on three core objectives: advancing the EscharEx VALUE Phase III trial, completing the commissioning of the expanded manufacturing facility, and building global recognition of EscharEx through clinical collaborations and publications [17] - The company has established new collaborations with ConvaTec and SCT to support ongoing trials, reinforcing the validation of EscharEx within the wound care ecosystem [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving several key milestones over the next twelve months, which are expected to advance strategic and financial objectives [5] - The company noted that the demand for NexoBrid is rising, and they are addressing capacity issues to support global growth [67] Other Important Information - The company received an additional $3.6 million in non-dilutive funding from the U.S. Department of Defense, bringing total program funding to $18.2 million [9] - As of June 30, 2025, the company had $32.9 million in cash and cash equivalents, down from $43.6 million at the end of 2024 [14] Q&A Session Summary Question: Are there any upcoming publications to be aware of? - Management indicated that there are several publications planned, particularly focusing on diabetic foot ulcer trials, with expectations for additional publications around major conferences [20] Question: Can you provide an update on the head-to-head trial versus Santyl? - The randomized study comparing EscharEx directly to collagenase is on track, with plans to enroll 45 VLU patients [21] Question: What is the status of the U.S. facility and BARDA funding? - The U.S. facility planning is fully funded by BARDA, and the company is preparing for the next steps in discussions with the U.S. government regarding the facility's funding [23][24] Question: How is the patient recruitment for the VALUE study progressing? - Enrollment is progressing well, with most U.S. sites active and recruiting, while European site activation is slightly slower due to regulatory timelines [41] Question: What areas are underserved for NexoBrid? - Demand is substantial across all regions, and the company is focused on meeting guidance for upcoming years, with expectations for better clarity on demand after the new facility is completed [46] Question: What are the expected timelines for the new NexoBrid facility? - The company expects to file for regulatory approvals in the EU and the U.S. in 2026, with EMA approval anticipated first [68]

Core Insights - MediWound Ltd. reported a revenue of $5.7 million for Q2 2025, reflecting a 43% increase from the previous quarter [5][12] - The company is actively enrolling patients in the VALUE Phase III trial for EscharEx, targeting 216 patients across 40 sites in the U.S. and Europe [6][2] - NexoBrid is gaining commercial traction in the U.S., with a reported 52% year-over-year revenue growth [6][2] Clinical Developments - The VALUE Phase III trial for EscharEx is ongoing, with an interim sample size assessment planned for mid-2026 [6] - New collaborations with Essity and Convatec have been established to support EscharEx trials, enhancing the company's clinical partnerships [6][2] - The trial now includes JOBST for compression therapy and will incorporate AQUACEL for wound dressing in the planned DFU trial [6] Financial Performance - Revenue for the first half of 2025 was $9.7 million, compared to $10.0 million in the same period of 2024 [12] - Gross profit for Q2 2025 was $1.3 million, representing 23.5% of total revenue, an improvement from 8.8% in the prior-year period [12] - Research and development expenses increased to $3.5 million in Q2 2025, driven by investments in the EscharEx VALUE Phase III trial [12] Manufacturing and Expansion - The commissioning of MediWound's expanded manufacturing facility is on track, with full operational readiness expected by year-end 2025 [6][2] - The facility is designed to increase NexoBrid production capacity six-fold to meet anticipated demand [6] Funding and Financial Position - The company received an additional $3.6 million in funding from the U.S. Department of Defense to advance NexoBrid's development [6] - As of June 30, 2025, MediWound had cash and cash equivalents of $32.9 million, down from $43.6 million at the end of 2024 [8]

Core Insights - MediWound Ltd. announced the publication of a post hoc analysis demonstrating a strong correlation between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs) [1][4] Group 1: Study Details - The analysis included data from 119 chronic VLU patients randomized in a 3:3:2 ratio to receive treatments with either EscharEx, a placebo gel, or non-surgical standard care, followed by weekly dressings for 12 weeks [2] - WBP was defined as the complete removal of nonviable tissue and full coverage of the wound bed with healthy granulation tissue [2] Group 2: Key Findings - Wounds that failed to achieve WBP had a 90% probability of not healing, indicating a high negative predictive value [7] - Wounds that achieved WBP were 4.1 times more likely to close compared to those that did not, with a statistical significance of p = 0.0004 [7] - Early achievement of WBP (within 14 days) significantly increased the likelihood of healing, with a relative risk of 2.4 (p = 0.0005) [7] - Wounds that did not reach WBP had a 12-fold higher risk of remaining unhealed throughout the study period (hazard ratio = 12, p < 0.0001) [7] Group 3: Implications for Therapy - The findings reinforce the clinical importance of complete debridement and timely full granulation tissue coverage in facilitating wound closure [4] - EscharEx has demonstrated therapeutic potential to improve healing outcomes by accelerating wound bed preparation in patients with venous leg ulcers [4][5] Group 4: About EscharEx - EscharEx is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds, showing a favorable safety profile and effective wound bed preparation [6] - A global Phase III study in venous leg ulcers is currently underway, with a clinical study in diabetic foot ulcers in preparation [6]

Core Insights - Vericel reported a 20% year-over-year GAAP revenue growth in Q2 2025, reaching $63.2 million, driven by its MACI franchise, despite missing analyst expectations of $64.5 million [1][2] - The company achieved a gross margin of 74%, an increase of 4 percentage points from the previous year, and narrowed its net loss per share to $0.01, outperforming the estimated loss of $0.03 [1][2][8] Financial Performance - Revenue for Q2 2025 was $63.2 million, up from $52.7 million in Q2 2024, reflecting a 20% increase [2] - Adjusted EBITDA (Non-GAAP) reached $13.4 million, a 112% increase from $6.3 million in Q2 2024 [2] - Operating cash flow was reported at $8.2 million, with cash reserves of approximately $164 million and no long-term debt [2][8] Product Performance - MACI, the cartilage repair implant, generated $53.5 million in revenue, a 21% increase year-over-year, and saw a significant rise in biopsies, indicating future revenue potential [5][6] - In burn care, Epicel and NexoBrid generated revenues of $8.6 million and $1.2 million, respectively, with Epicel revenue increasing from $7.8 million and NexoBrid growing by 52% from $0.8 million [7] Business Strategy - The company is focused on expanding the usage of its products, training more physicians, and enhancing delivery methods, such as the new arthroscopic technique for MACI [4][6] - Management plans to expand the MACI sales force in the second half of 2025 to align with expected demand and surgeon training momentum [11] Market Outlook - Management expects full-year MACI revenue growth in the low 20% range and a stable run rate of approximately $10 million per quarter for burn care in the second half of 2025 [12] - Vericel received FDA clearance for a Phase 3 study of MACI for ankle cartilage repair, potentially opening a new market worth an estimated $1 billion annually [11]