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 ...

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]

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]

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]

Financial Data and Key Metrics Changes - The company achieved record total net revenue of $52.6 million for Q1 2025, with MACI revenue of $46.3 million, Epicel revenue of $5 million, and NexoBrid revenue of $1.3 million [12] - MACI revenue grew by 15% year-over-year, which adjusts to approximately 17% growth when accounting for one fewer selling day in the quarter [12] - NexoBrid revenue increased by 207% year-over-year and 31% sequentially [12] - 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 [15] 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] - NexoBrid revenue showed significant growth, indicating progress in its launch and deeper penetration in ordering centers [10] - Epicel revenue was lower than anticipated due to a high percentage of canceled cases related to patient health issues, despite the highest number of biopsies since 2023 [10][13] Market Data and Key Metrics Changes - The company expects total revenue growth of 22% to 25% for Q2 2025, with MACI revenue projected to be approximately $54 million [17] - The addressable market for MACI is estimated at 60,000 patients annually, with significant opportunities in treating femoral condyle and trochlear defects [24][25] Company Strategy and Development Direction - The company plans to expand its MACI sales force in the second half of 2025, driven by strong early indicators from the MACI Arthro launch [9][19] - The MACI Ankle Development Program is on track to initiate Phase III clinical studies, representing a substantial long-term growth driver with an estimated market of $1 billion [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about strong underlying MACI business fundamentals and early indicators from the MACI Arthro launch, suggesting potential for incremental growth [20] - The company reaffirmed its full-year revenue guidance of 20% to 23% growth and raised profitability guidance, expecting gross margins to reach 75% and adjusted EBITDA margins to 26% for the year [17] Other Important Information - The company ended the quarter with approximately $162 million in cash, restricted cash, and investments, with no debt [15] - Management noted that tariffs are expected to have a negligible impact on the business due to domestic manufacturing and significant safety stock [16] 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, representing a significant portion of the addressable market, and surgeons are also using them for trochlear defects, expanding the potential market [24][25] Question: How do you see seasonality and pacing for MACI in the second half of the year? - Management acknowledged that while MACI typically follows a seasonal pattern, strong leading indicators suggest potential for enhanced growth in the second half of the year [30][31] Question: What is the contribution of MACI Arthro to the first quarter numbers? - Management noted that while it is difficult to quantify the exact contribution from MACI Arthro in Q1, they expect a more significant impact in the second half of the year [36][37] Question: How are you prioritizing MACI Arthro training among surgeon groups? - Management explained that training occurs through industry events and individual sessions, focusing first on existing MACI users before targeting new surgeons [92][93] Question: How has the recent trade war impacted your view on MACI internationally? - Management stated that they are evaluating the potential for MACI outside the U.S. and will consider trade impacts before making decisions [90][91]