CAMBRIDGE, Mass., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the Company will participate in a fireside chat at the Wells Fargo Healthcare Conference at 3:45 p.m. ET on Thursday, September 4, 2025. A webcast of the presentation will be available on the Investor Relations section of the Vericel Corporation website at: http://investors.vcel.com. About Vericel Corporation Vericel ...

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. 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]

Core Viewpoint - MediWound Ltd. is set to release its financial results for the second quarter of 2025 on August 14, 2025, and will host a conference call to discuss these results and provide corporate updates [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 developing EscharEx, a late-stage investigational therapy aimed at chronic wound debridement, which has shown clinical advantages over existing products and targets a significant global market opportunity [3].

Financial Data and Key Metrics Changes - Total revenue increased by 20% in the second quarter, reaching $63.2 million, with gross margin expanding over 400 basis points to 74% [5][12][16] - Adjusted EBITDA rose by 112% year-over-year to over $13.4 million, representing 21% of revenue, an increase of more than 900 basis points compared to the previous year [5][17] - Net loss narrowed to $600,000 or $0.01 per share, an improvement of over $4 million compared to the prior year [17] Business Line Data and Key Metrics Changes - MACI generated record revenue of nearly $54 million, reflecting a 21% increase year-over-year and 15% sequential growth [5][12] - Epicel revenue was $8.6 million, representing an 11% growth year-over-year, with biopsies increasing nearly 40% [14][15] - NexoBrid revenue reached $1.2 million, showing a 52% growth compared to the prior year [15] Market Data and Key Metrics Changes - MACI biopsy growth rates outpaced implant growth, with expectations for convergence in the second half of the year [6][7] - The treatment of small femoral condyle defects increased by 40% year-over-year, indicating strong market potential [7][8] - Epicel's performance rebounded with the highest monthly biopsies recorded in June [9][10] Company Strategy and Development Direction - The company plans to expand its MACI sales force from 76 to approximately 100 territories to support anticipated growth [8][10] - FDA clearance for the Phase III MACI Ankle clinical study was received, representing a significant long-term growth opportunity [10][11] - The company is focused on maintaining strong revenue and profitability growth while preparing for international expansion, particularly in Europe [85] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong underlying business fundamentals and growth drivers for MACI and burn care products [5][20] - The company is optimistic about the third quarter, citing strong momentum from both MACI and burn care products [10][20] - Management acknowledged challenges in predicting Epicel revenue due to patient health-related issues but remains hopeful for improved performance [39][40] Other Important Information - The company ended the second quarter with approximately $164 million in cash and investments and no debt [17] - The company is not assuming additional NexoBrid revenue related to the BARDA RFP process but sees potential for incremental revenue in the fourth quarter [18][19] Q&A Session Summary Question: What impacted MACI growth in Q2? - Management noted that Q2 revenue was slightly below expectations due to timing issues with some implants moving into July, but overall metrics remain strong [24][25] Question: How many arthrobiopsies have converted to MACI? - Management did not disclose specific conversion rates but indicated that trends are in line with expectations [28][29] Question: What is the new reality for Epicel guidance? - Management explained that while biopsies were up significantly, patient health issues have affected revenue, leading to a more conservative guidance for the second half of the year [32][34] Question: Can you discuss the BARDA RFP? - Management confirmed that the RFP is in the public domain, with proposals due in late August, and initial procurement would be for 2,750 units [92][93]

Financial Data and Key Metrics Changes - Total revenue increased by 20% in Q2 2025, reaching $63.2 million, with gross margin expanding over 400 basis points to 74% [4][12] - Adjusted EBITDA rose by 112% year-over-year to over $13.4 million, representing 21% of revenue, an increase of more than 900 basis points compared to the previous year [4][17] - Net loss narrowed to $600,000 or $0.01 per share, an improvement of over $4 million compared to the prior year [17] Business Line Data and Key Metrics Changes - MACI generated record revenue of nearly $54 million in Q2, reflecting a 21% increase year-over-year and 15% sequential growth [4][12] - Epicel revenue was $8.6 million, representing an 11% growth year-over-year, with biopsies increasing nearly 40% compared to the prior year [12][14] - NexoBrid revenue reached $1.2 million, showing a 52% increase year-over-year, with strong growth in hospital unit orders [14] Market Data and Key Metrics Changes - MACI's performance was driven by strong growth in the surgeon base and biopsy volumes, with the second highest number of MACI biopsies recorded since launch [5][6] - The treatment of small femoral condyle defects increased by 40% year-over-year, indicating potential for significant growth in this segment [6][10] - Epicel's biopsies were the highest in any quarter since 2023, with a strong start in Q3 [9][10] Company Strategy and Development Direction - The company plans to expand its MACI sales force from 76 to approximately 100 territories to support anticipated high volumes in Q4 2025 [8][10] - FDA clearance for the Phase III MACI Ankle clinical study was received, representing a substantial long-term growth driver for MACI [10][11] - The company is also on track to initiate commercial manufacturing for MACI in a new facility next year [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong underlying business fundamentals and growth drivers for MACI and burn care products [4][20] - The company is well-positioned for a strong second half of the year, with expectations for continued revenue and profitability growth [10][20] - Management acknowledged challenges in predicting Epicel quarterly revenue due to patient health-related issues but remains optimistic about future performance [38][40] Other Important Information - The company ended Q2 with approximately $164 million in cash and investments and no debt, enhancing its financial profile [17] - The guidance for MACI revenue growth for the full year remains in the low 20% range, with updates to burn care revenue guidance reflecting recent run rates [18][19] Q&A Session Summary Question: What is impacting MACI growth guidance? - Management noted that Q2 revenue was slightly below expectations but emphasized strong underlying indicators and expected acceleration in growth moving forward [24][25] Question: How many arthrobiopsies have converted to MACI? - Management stated they do not disclose specific conversion rates but indicated that trends are in line with expectations [28][29] Question: What is the new reality for Epicel guidance? - Management explained that while biopsies were up significantly, patient health issues have impacted revenue, leading to a more conservative guidance approach [32][34] Question: Can you comment on international expansion opportunities? - The company is prioritizing Europe for expansion and expects to have a roadmap for international opportunities by the end of the year [83][84] Question: What is the BARDA RFP about? - The RFP involves procurement for stockpiling and includes multiple funding opportunities, with proposals due in late August [92][93]

Financial Performance - Total Q2 Revenue reached $63.2 million[6], with MACI contributing $53.5 million[6], Epicel $8.6 million[6], and NexoBrid $1.2 million[6] - MACI revenue experienced a growth of 21% reaching $53.5 million[10] - Gross margin increased to 74%, up over 400 bps compared to Q2 2024[10] - Adjusted EBITDA increased by 112% to $13.4 million[10] - The company holds $164 million in cash and investments[10] Business Highlights - Approximately 600 surgeons have been trained on MACI Arthro to date[10] - MACI implants for small femoral condyle defects increased by more than 40% in Q2 compared to the prior year[10] - NexoBrid second quarter revenue increased 52% vs prior year[10] - The company received FDA IND clearance for the MACI Ankle clinical study and remains on track to initiate the study in 2H 2025[10] MACI Arthro Launch - MACI Arthro trained surgeons continue to demonstrate expanded MACI utilization[14] - MACI implants for trochlea defects account for nearly 20% of MACI Arthro implants to date[14]

Financial Performance - Total net revenue for Q2 2025 increased by 20% to $63.2 million compared to $52.7 million in Q2 2024 [7][9] - MACI net revenue grew by 21% to $53.5 million, while Burn Care net revenue was $9.8 million, consisting of $8.6 million from Epicel and $1.2 million from NexoBrid [7][9] - Gross margin improved by over 400 basis points to 74% from 70% in the prior year [10][7] - Adjusted EBITDA rose by 112% to $13.4 million, with an adjusted EBITDA margin increase of over 900 basis points to 21% [2][12] Business Highlights - Approximately 600 MACI Arthro surgeons have been trained to date [2] - The company received FDA IND clearance for the Phase 3 MACI Ankle clinical study, expected to initiate in the second half of 2025 [7][9] - The second quarter saw the second highest number of MACI biopsies since launch, with a more than 40% increase in MACI implants for small femoral condyle defects compared to the previous year [7][9] - Epicel biopsies reached the highest number in a quarter since 2023, representing a 38% growth year-over-year [7] Financial Guidance - The company reaffirmed MACI full-year revenue growth in the low 20% range and updated Burn Care revenue guidance for the second half of 2025 to approximately $10 million per quarter [8] - Full-year profitability guidance includes a gross margin of 74% and an adjusted EBITDA margin of 26% [8]