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 - 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]

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]

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 [3] Upcoming Financial Results - Vericel will report its second-quarter 2025 financial results on July 31, 2025, with a conference call and webcast scheduled for 8:30 a.m. ET [1] - The live webcast can be accessed through the Investor Relations section of the Vericel website, and a replay will be available until July 31, 2026 [2] Product Portfolio - Vericel markets three main products in the United States: - MACI: An autologous cellularized scaffold product for repairing full-thickness cartilage defects in the knee [3] - Epicel: A permanent skin replacement for treating deep dermal or full-thickness burns covering 30% or more of total body surface area [3] - NexoBrid: A biological orphan product for eschar removal in burn patients, for which Vericel holds exclusive North American rights [3]

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]

Company Overview - Vericel is a leader in advanced cell therapies for the sports medicine and severe burn care markets[6, 11, 18, 22, 99] - The company utilizes an innovative advanced therapy platform, combining devices and biologics that use a patient's own cells to repair tissue and restore function[10] Financial Performance & Market Opportunity - The company achieved 45% trailing twelve-month product revenue growth[12] - Total trailing twelve-month product revenues reached $90.9 million as of December 31, 2018[13] - Vericel is operating in addressable markets valued at over $2 billion[14] - The company has cash and short-term investments of approximately $83 million with no debt as of December 31, 2018[22, 98] MACI Product Highlights - Cartilage defects are found in approximately 60% of knee arthroscopies[33, 34] - MACI demonstrated statistically significantly greater improvement in KOOS pain and function scores compared to microfracture at year 2 (p = 0.001)[52, 53] - 87.50% of patients responded to MACI treatment compared to 68.10% with microfracture (p = 0.016)[55, 56] Epicel Product Highlights - Epicel is a permanent skin replacement for full-thickness burns covering 30% or more of the total body surface area[76] - Data demonstrates a lower mortality rate for Epicel patients compared to the National Burn Repository[82] - The addressable market for Epicel in the U S is estimated at $120 million[86]

Financial Performance - Total revenue for Q4 2019 increased by 26% compared to Q4 2018[5] - Full-year 2019 MACI revenue grew by 35%[5] - Full-year 2019 Epicel revenue grew by 13%[5] - Gross margin expanded by 66 basis points in Q4 2019 compared to Q4 2018[5] - Adjusted EBITDA improved by $5.1 million in Q4 2019 compared to Q4 2018[5] - Net product sales for the full year 2019 were $117.85 million, compared to $90.857 million in 2018[16] Revenue Details - Q4 2019 total revenue was $33.6 million[9] - Full-year 2019 total revenue was $91.6 million[11] Guidance and Future Expectations - Full-year 2020 revenue guidance is $141-$146 million[6] - Full-year MACI revenue is expected to grow by approximately 26% in 2020[19]