CAMBRIDGE, Mass., Oct. 23, 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 report its third-quarter 2025 financial results on Thursday, November 6, 2025. Vericel’s management will host a conference call and webcast at 8:30 a.m. ET to discuss its financial results and business highlights. The live webcast can be accessed on the Investor Relations section of the Vericel websit ...

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Core Viewpoint - BTIG downgraded Vericel Corporation from Buy to Neutral, removing its previous price target of $45, leading to a more than 7% decline in shares [1] Group 1: Share Performance and Market Sentiment - Vericel shares have dropped approximately 42% year-to-date following two weaker quarters [2] - The downgrade reflects a lack of expected growth from the MACI Arthro launch, with a survey indicating that around 60% of physicians anticipate no change in MACI volumes [2] Group 2: Growth Projections - BTIG projected a 20% increase in MACI procedure growth for fiscal 2026, aligning with Street estimates, followed by a slower average growth of 14.8% annually through fiscal 2028 [3] - The firm expects mid-to-high-teens overall growth, which is below consensus forecasts for fiscal 2026 and beyond [3] Group 3: Valuation and Investor Interest - Shares are currently trading at about 5x next-twelve-month EV/Sales, with much of the current weakness already reflected in the valuation [4] - Without clear upside catalysts, BTIG concluded that investor interest may not return in the near term [4]

Group 1 - The stock of Vericel Corporation (VCEL) is experiencing significant attention due to high implied volatility in the options market, particularly for the Oct. 17, 2025 $30 Call option [1] - Implied volatility indicates the market's expectation of future price movement, suggesting that investors anticipate a significant change in Vericel's stock price, potentially due to an upcoming event [2] - Currently, Vericel holds a Zacks Rank 4 (Sell) in the Medical - Biomedical and Genetics industry, with no analysts increasing earnings estimates for the current quarter and three analysts reducing their estimates, leading to a consensus estimate shift from earnings of 5 cents per share to a loss of 2 cents [3] Group 2 - The high implied volatility surrounding Vericel may indicate a developing trading opportunity, as options traders often seek to sell premium on options with high implied volatility to benefit from time decay [4]

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]

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 - 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]