Company Overview and Financial Performance - Vericel is a leader in advanced therapies in sports medicine and burn care, combining innovations in biology with medical technologies[5] - The company has a strong financial profile with ~$162 million in cash and investments[9] - Vericel achieved GAAP Net Income positive in 2024[9] - The company is driving high revenue growth and targets high-70% gross margin and high-30% adjusted EBITDA in the mid-term[17] - The company experienced 20% top-line growth in 2024 and expects continued high revenue growth in 2025 and beyond[18] Market Opportunity and Product Expansion - The total addressable market (TAM) opportunity is expanding to over $5 billion in the years ahead[10] - The core TAM is ~$4 billion, with an expanded TAM of ~$5 billion[11, 12] - MACI Arthro, launched in Q3 2024, targets the largest segment of the current MACI addressable market[9] - MACI Ankle study is anticipated to initiate in 2025, potentially increasing the total MACI addressable market to $4 billion[9, 53] - NexoBrid, launched in the U S in Q4 2023, significantly expands the total addressable market in burn care[9]

Continued Strong Revenue Growth Translated Into Significant Profit Growth Q4 2019 Financial Performance vs. Q4 2018 Business Highlights MACI full-year revenue growth of 35%, Epicel full- Vericel Q4 2019 Financial Results – February 25, 2020 3 +26% +66 bps +$5.1 million Total Revenue Growth Gross Margin Expansion Adjusted EBITDA Improvement VERICEL Q4 2019 RESULTS FEBRUARY 25, 2020 Safe Harbor This presentation contains forward-looking statements, including, without limitation, statements regarding full-year ...

CAMBRIDGE, Mass., June 10, 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 Truist Securities MedTech Conference at 9:20 a.m. ET on Tuesday, June 17 2025. Eric Burns ir@vcel.com +1 (734) 418-4411 Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets. The Company combines innovations in bi ...

MediWound (MDWD) Q1 2025 Earnings Call May 21, 2025 08:30 AM ET Company Participants Dan Ferry - Managing DirectorOfer Gonen - Chief Executive OfficerHani Luxenburg - Chief Financial OfficerRamakanth Swayampakula - Managing DirectorBarry Wolfenson - Executive Vice President of Strategy & Corporate Development Conference Call Participants Chase Knickerbocker - Senior Equity Research Analyst - HealthcareMichael Okunewitch - Senior Biotechnology AnalystScott Henry - Managing Director & Senior Research Analyst ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $4 million, down from $5 million in Q1 2024, primarily due to lower revenue from BARDA funded development services as the NexoBrid development program nears completion [17] - Gross profit for the quarter was $700,000, representing a gross margin of 19%, compared to $600,000 and a gross margin of 12% in the prior year [17] - R&D expenses totaled $2.9 million, up from $1.5 million in Q1 2024, reflecting continued investment in the EscharEx VALUE Phase III trial [17] - SG&A expenses were $3.1 million, compared to $2.9 million in the prior year [17] - Operating loss for the quarter was $5.2 million, compared to $3.7 million in Q1 2024 [17] - Net loss was $700,000 or $0.07 per share, an improvement from a net loss of $9.7 million or $1.05 per share last year [17] - Adjusted EBITDA loss for the quarter was $4 million, compared to $2.9 million in the prior year [17] - Cash, cash equivalents, and deposits as of March 31, 2025, were $38.7 million, down from $43.6 million at year-end 2024 [19] Business Line Data and Key Metrics Changes - The VALUE Phase III study for EscharEx is on track, with recruitment progressing as planned, aiming to enroll 216 patients across approximately 40 sites in the U.S. and Europe [5][6] - NexoBrid's U.S. adoption continues to expand, with a 207% year-over-year increase and a 31% sequential increase in revenue during Q1 2025 [12] - Demand for NexoBrid in Japan and Europe continues to exceed manufacturing capacity, with a new manufacturing facility expected to be operational by year-end 2025 [12][13] Market Data and Key Metrics Changes - The company has secured a €2,500,000 grant from the European Innovation Council Accelerator to support the clinical and regulatory advancement of EscharEx for diabetic foot ulcers [9] - The U.S. government has expressed interest in establishing a domestic backup manufacturing site for NexoBrid, supported by BARDA [15][25] Company Strategy and Development Direction - The company is focused on scaling manufacturing capabilities to support long-term growth, with a new facility progressing on schedule and U.S. expansion plans underway [21] - EscharEx is positioned to become a global leader in enzymatic wound debridement, with strong clinical advantages over competitors [11] - The company is advancing complementary studies to support market access and future commercial success [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical, commercial, and operational priorities, maintaining momentum from 2024 [4] - The company anticipates achieving operational capacity for the new manufacturing facility by the end of 2025, with regulatory inspections expected thereafter [25] - Management remains optimistic about the VALUE Phase III trial and expects interim data by mid-2026 [31] Other Important Information - The company is planning a 45-patient randomized prospective Phase II head-to-head comparison of EscharEx versus collagenase, scheduled to begin in the second half of 2025 [7] - The pediatric Phase III study results for NexoBrid were published, reinforcing its efficacy and safety [13] Q&A Session Summary Question: What is yet to be done for manufacturing scale-up by year-end? - The construction of the new facility is complete, and the company is in the commissioning phase, expecting operational capacity by the end of 2025 [25] Question: When should investors expect movement on U.S. capacity? - The project for a domestic backup manufacturing site is expected to be finished by Q3 this year, with further details to follow [28] Question: How is enrollment progressing for the VLU study? - Recruitment is progressing as planned, with excitement from leading wound care companies and key opinion leaders [31] Question: How is the stockpiling of NexoBrid being planned? - The company prefers to treat patients rather than stockpile, but there is growing interest from governments for stockpiling [37] Question: What is the structure of the EscharEx trial sites? - Approximately 50% of the sites will be in the U.S., with a focus on recruiting the right patients [39] Question: Will the results of the head-to-head study and phase three study come around the same time? - The head-to-head study is expected to finish ahead of the phase three study due to its shorter duration [43] Question: What factors will influence the pricing strategy for EscharEx? - The pricing strategy will consider treatment costs, health economics, and potential savings from faster debridement [51] Question: How should investors think about BARDA and DoD funding? - The company anticipates no material impact on revenue outlook for 2025, with programs back on track [61]

"We entered 2025 with strong execution across our clinical, commercial, and operational priorities, maintaining the momentum established in 2024," said Ofer Gonen, Chief Executive Officer of MediWound. "The VALUE Phase III study for EscharEx remains on schedule, and our additional collaboration with Kerecis marks a significant milestone—bringing nearly all leading global wound care companies into our clinical research programs. Meanwhile, NexoBrid continues to gain global traction, as we advance strategic m ...

Summary of Vericel (VCEL) 2025 Conference Call Company Overview - **Company**: Vericel Corporation - **Industry**: Advanced therapies for sports medicine and severe burn care markets - **Key Products**: MACI (cell therapy for cartilage repair), NexoBrid (eschar removal), Epicel (permanent skin replacement) [1][2][4] Core Points and Arguments Product Leadership - Vericel is a leader in advanced therapies with a unique portfolio of specialty biologics and advanced cell therapies [2][3] - MACI is the leading restorative cartilage repair product and the only FDA-approved product in its class [3][5] - Recent FDA approval for AC Arthro is expected to enhance market penetration [3] Financial Performance - The company has shown significant revenue growth, with a compounded annual growth rate of approximately 20% since the launch of MACI in 2017 [9][11] - Burn care franchise grew by 22% last year, indicating strong performance in both segments [8] - Strong financial position with over $160 million in cash and no debt [7] Market Opportunity - Total Addressable Market (TAM) for the core portfolio is approximately $4 billion, potentially increasing to over $5 billion with the addition of MACI ankle indications [9] - There are about 750,000 knee cartilage repair procedures annually, with a significant commercial opportunity for MACI [13] Growth Initiatives - Plans to initiate a MACI ankle study and expand manufacturing capabilities to support international launches [8][10] - The MACI Arthro launch is expected to simplify procedures and increase market penetration [16][19] Burn Care Innovations - NexoBrid is positioned to change the standard of care for burn treatment by providing a less traumatic eschar removal method [22][23] - Epicel is the only FDA-approved permanent skin replacement, showing significant survival benefits for patients [26] Adoption and Training - Over 400 surgeons trained for MACI Arthro, with a biopsy growth rate exceeding 30% among trained surgeons [20][19] - Focus on expanding the commercial footprint and increasing utilization of both NexoBrid and Epicel [26][27] Additional Important Content - The company emphasizes the lack of near-term competitors and significant barriers to entry in the market [5][6] - The innovative nature of MACI and its broad label contribute to its market leadership [15] - Continuous exploration for new products in sports medicine and burn care markets to leverage existing capabilities [28]

YAVNE, Israel, May 13, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the publication of a peer-reviewed post hoc analysis in Wounds. The analysis is based on data from the Company’s Phase II ChronEx clinical trial in patients with venous leg ulcers (VLUs) evaluating the efficacy and safety of EscharEx® compared with collagenase ointment (SANTYL®), the only FDA-cleared enzymatic debridement agent commercial ...

报名：首届全球心血管大会 | 最新议程 合作伙伴征集：2025全球手术机器人大会 2025年5月9日，新医疗科技巨头 舒万诺 Solventum （纽交所代码：SOLV） 公布了2025年第一季度财报表现。该季度销售额为 21亿美元 （约143亿元人民币），同 比增长 2.7% ， 调整后的每股收益（EPS）为 1.34美元 ，均超出市场预期。 股价因此上涨 5% ，收于 70.02美元 。 自2024年4月从3M分拆以来， Solventum已迅速进入独立运营阶段，并在2025年第一季度交出了亮眼的财报。本文将深入分析舒万诺的财务表现、战略转型进展以 及面临的挑战和风险。 # 财务表现与未来展望 2025年第一季度， Solventum 在各大业务板块的表现强劲，具体财务数据如下： MedSurg（医疗外科） ： 销售额为 12.81亿美元 （约61%），同比增长 3.4% ，主要得益于 V.A.C.负压伤口治疗系统 和 Tegaderm透明敷料 的市场需求。 Dental Solutions（牙科解决方案） ： 销售额为 3.36亿美元 （约16%），同比增长 0.4% ，其中， SprintRay合作 ...

Financial Data and Key Metrics Changes - The company achieved record total net revenue of $52.6 million for the first quarter, with MACI revenue of $46.3 million, Epicel revenue of $5 million, and NexoBrid revenue of $1.3 million [13] - MACI revenue grew by 15% year-over-year, which adjusts to approximately 17% growth when accounting for one fewer selling day in the quarter [14] - NexoBrid revenue increased by 207% year-over-year and 31% sequentially [14] - The net loss for the quarter was $11.2 million, or $0.23 per share, with non-GAAP adjusted EBITDA of $3.2 million, representing 6% of net revenue [16] Business Line Data and Key Metrics Changes - MACI had a strong quarter with record revenue exceeding $46 million, driven by strong underlying fundamentals and a growing surgeon customer base [6][5] - NexoBrid's revenue growth was significant, with over 200% increase compared to the previous year, indicating strong market penetration [10] - Epicel revenue was lower than anticipated due to a high percentage of canceled cases, but there was a strong start to the second quarter with graft volumes exceeding the first quarter [11][12] Market Data and Key Metrics Changes - The company expects total revenue growth of 22% to 25% for the second quarter, with MACI revenue projected to be approximately $54 million [18] - The addressable market for MACI is estimated at 60,000 patients annually, with significant opportunities in femoral condyle and trochlear defects [26][20] Company Strategy and Development Direction - The company is advancing the MACI Ankle Development Program and plans to initiate a Phase III clinical study in the second half of the year, which represents a substantial long-term growth driver [20] - The company plans to expand its MACI sales force in the second half of the year to support growth driven by MACI Arthro [10][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about strong second quarter performance based on positive trends observed in the first quarter, reaffirming full-year revenue guidance of 20% to 23% growth [5][17] - The company anticipates minimal impact from tariffs due to its domestic manufacturing and significant safety stock of materials [17] Other Important Information - The company generated $6.6 million in operating cash flow and ended the quarter with approximately $162 million in cash and no debt [16] - Management raised profitability guidance for the year, expecting gross margins to reach 75% and adjusted EBITDA margins to reach 26% [18] Q&A Session Summary Question: Can you discuss the market opportunity for femoral condyle and trochlear specifically? - Management indicated that the MACI Arthro instruments are designed for femoral condyle defects, which represent a significant portion of the addressable market, and there is potential for treating trochlear defects as well [26][27] Question: How do you see seasonality and pacing for MACI in the second half of the year? - Management noted that while MACI typically follows a prescriptive pattern, strong leading indicators suggest potential for stronger growth in the second half of the year [32][33] Question: What is the contribution of MACI Arthro to first quarter numbers? - Management acknowledged that while there was some incremental impact from MACI Arthro, the full effect is expected to be seen in the second half of the year [38][40] Question: How have recent trade war headlines impacted international views on MACI? - Management stated that they are evaluating potential for MACI outside the U.S. but will consider tariffs and trade impacts before making decisions [92] Question: Can you provide insights on conversion rates for MACI Arthro procedures? - Management indicated that it is early to assess conversion rates, but they expect higher rates over time due to the less invasive nature of the procedure [57][66] Question: What are the dynamics of cross-selling opportunities between Epicel and NexoBrid? - Management confirmed that they are seeing biopsies from previously dormant accounts and expect this trend to continue as they cross-sell products [61] Question: Can you elaborate on the sales force expansion plans? - Management indicated that while the expansion is not full-scale this year, they are preparing to add resources to support expected growth [80][81]