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]

Core Viewpoint - The company has reported a strong start to the year with record first quarter MACI and total revenue, indicating positive growth and performance in the market [5]. Group 1: Company Performance - The company achieved record first quarter MACI revenue, reflecting strong demand and operational efficiency [5]. - Total company revenue also reached a record high in the first quarter, showcasing overall business growth [5]. Group 2: Leadership and Communication - The earnings call featured key executives including the CEO, Nick Colangelo, and CFO, Joe Mara, highlighting the leadership team's involvement in discussing the company's performance [2][4]. - The call was structured to provide insights into the company's financial results and future outlook, with a reminder about forward-looking statements and associated risks [3].

Core Viewpoint - Vericel Corporation reported a quarterly loss of $0.23 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.09, marking an earnings surprise of -155.56% [1] Financial Performance - The company posted revenues of $52.6 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 2.73%, compared to revenues of $51.28 million a year ago [2] - Over the last four quarters, Vericel has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [2] Stock Performance - Vericel shares have declined approximately 26.3% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] - The current Zacks Rank for Vericel is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.03 on revenues of $65.24 million, and for the current fiscal year, it is $0.32 on revenues of $286.96 million [7] - The estimate revisions trend for Vericel is mixed, and changes in estimates for the coming quarters and current fiscal year are anticipated following the recent earnings report [6][7] Industry Context - The Medical - Biomedical and Genetics industry, to which Vericel belongs, is currently in the top 33% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8]

Vericel (VCEL) Q1 2025 Earnings Call May 08, 2025 08:30 AM ET Company Participants Eric Burns - Vice President of Finance & Investor RelationsDominick Colangelo - President & CEOJoe Mara - Chief Financial OfficerRichard Newitter - Managing DirectorJoshua Jennings - Managing DirectorCaitlin Cronin - Director Conference Call Participants Ryan Zimmerman - Managing Director & Medical Technology AnalystNone - AnalystMason Carrico - Research Analyst Operator Thank you for standing by. My name is Roselle, and I wi ...

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]

Revenue Performance - Total revenue for Q1 2025 was $52.6 million, a 2.6% increase from $51.3 million in Q1 2024, driven primarily by MACI volume and price growth [102]. - MACI revenue increased by 15.2% to $46.3 million in Q1 2025, compared to $40.2 million in Q1 2024 [103]. - NexoBrid revenue surged by 206.7% to $1.3 million in Q1 2025, up from $436,000 in Q1 2024 [103]. - Epicel revenue decreased by 53.5% to $4.96 million in Q1 2025, down from $10.7 million in Q1 2024 [103]. Profit and Loss - Gross profit for Q1 2025 was $36.3 million, reflecting a 2.6% increase from $35.4 million in Q1 2024 [102]. - The net loss for Q1 2025 was $11.2 million, a 191.2% increase from a net loss of $3.9 million in Q1 2024 [102]. - Gross profit for Q1 2025 increased due to MACI revenue growth and fixed manufacturing costs [105]. Expenses - Research and development expenses rose by 13.1% to $7.3 million in Q1 2025, compared to $6.4 million in Q1 2024 [102]. - Selling, general and administrative expenses increased by 21.5% to $41.8 million in Q1 2025, up from $34.4 million in Q1 2024 [102]. - Total research and development expenses rose to $7.261 million in Q1 2025, a 13.1% increase from $6.418 million in Q1 2024 [106]. - Selling, general and administrative expenses increased to $41.8 million in Q1 2025, up from $34.4 million in Q1 2024 [107]. Cash Flow and Financial Position - Net cash provided by operating activities was $6.6 million in Q1 2025, down from $7.2 million in Q1 2024 [110]. - Net cash used in investing activities was $15.142 million in Q1 2025, compared to $25.452 million in Q1 2024 [110]. - Net cash provided by financing activities increased to $3.198 million in Q1 2025 from $2.126 million in Q1 2024 [110]. - As of March 31, 2025, cash, cash equivalents, and restricted cash totaled $79.7 million [111]. - The company has a $150 million revolving credit agreement with no immediate plans to borrow [120]. - The company expects current cash resources to support operations for at least 12 months from the report date [118]. Product Development and Market Expansion - The MACI Arthro product became commercially available in Q3 2024, expanding the target surgeon base from 5,000 to 7,000 [96]. - The company plans to initiate a MACI Ankle clinical trial in 2025 to explore the potential for treating cartilage damage in the ankle [96]. - MACI sales volumes historically show seasonality, with Q4 averaging 34% of total annual volumes [104].

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 risks, assumptions, uncertainties and fact ...

Financial Performance - Total net revenue for Q1 2025 was $52.6 million, a 2.6% increase from $51.3 million in Q1 2024[7] - MACI net revenue reached $46.3 million, reflecting a 15% growth compared to the previous year[5] - Burn Care net revenue was $6.3 million, consisting of $5.0 million from Epicel and $1.3 million from NexoBrid[5] - Gross margin for Q1 2025 was 69%, consistent with the same period in 2024[8] - The net loss for Q1 2025 was $11.2 million, or $0.23 per diluted share, compared to a net loss of $3.9 million, or $0.08 per diluted share, in Q1 2024[12] - Non-GAAP adjusted EBITDA for Q1 2025 was $3.2 million, representing 6% of net revenue, down from $7.2 million, or 14% of net revenue, in Q1 2024[12] - Full-year total revenue guidance is reaffirmed with expected growth of 20% to 23%[10] - The company raised full-year profitability guidance to a gross margin of 74% and an adjusted EBITDA margin of 26%[10] - NexoBrid revenue increased by 207% year-over-year and 31% quarter-over-quarter[9] Asset and Liability Management - Total current assets decreased from $212,777 million in December 2024 to $197,640 million in March 2025, a decline of approximately 7.1%[26] - Cash and cash equivalents slightly decreased from $74,520 million to $73,490 million, a reduction of about 1.4%[26] - Total liabilities decreased from $140,755 million in December 2024 to $129,100 million in March 2025, a decrease of approximately 8.3%[26] - Total shareholders' equity increased from $291,967 million to $295,487 million, reflecting a growth of about 1.8%[26] - Accounts payable decreased significantly from $23,848 million to $16,751 million, a reduction of approximately 29.6%[26] - Accrued expenses decreased from $17,065 million to $11,418 million, a decline of about 33.3%[26] - Current liabilities decreased from $50,286 million to $39,448 million, a decrease of approximately 21.5%[26] - Long-term investments increased from $39,880 million to $43,342 million, reflecting an increase of about 8.7%[26] - Operating lease liabilities slightly decreased from $89,593 million to $87,804 million, a reduction of about 2.0%[26] - Total assets decreased from $432,722 million to $424,587 million, a decline of approximately 1.9%[26] Operational Highlights - The company trained approximately 400 MACI Arthro surgeons to date, with year-to-date biopsy growth exceeding 30% for trained surgeons[5]

Financial Performance - Total net revenue for Q1 2025 was $52.6 million, an increase from $51.3 million in Q1 2024 [5][21] - MACI net revenue grew by 15% to $46.3 million compared to the previous year [5][7] - Burn Care net revenue was $6.3 million, comprising $5.0 million from Epicel and $1.3 million from NexoBrid [5] - Gross margin remained stable at 69% [8] - The net loss for the quarter was $11.2 million, or $0.23 per diluted share, compared to a net loss of $3.9 million, or $0.08 per diluted share, in Q1 2024 [10][21] - Non-GAAP adjusted EBITDA for the quarter was $3.2 million, down from $7.2 million in Q1 2024 [10][22] Business Highlights - Approximately 400 MACI Arthro surgeons have been trained to date, with a year-to-date biopsy growth exceeding 30% for these trained surgeons [5][4] - The company reported the second highest number of MACI biopsies and surgeons taking biopsies since the product launch, with March recording the highest number of biopsies in any month since launch [5] - NexoBrid revenue increased by 207% year-over-year and 31% quarter-over-quarter [5] - Epicel saw the highest number of biopsies in a quarter since 2023 during Q1 2025 [5] Future Guidance - The company expects second quarter total revenue and MACI revenue growth to be in the low- to mid-20% range [5][6] - Full-year 2025 revenue guidance has been reaffirmed, with expected growth of 20% to 23% [6] - Profitability guidance has been raised to a gross margin of 74% and an adjusted EBITDA margin of 26% for the full year [6]

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 symptomatic, full-thickness cartilage defects of the knee in 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 present at the Bank of America Securities 2025 Healthcare Conference on May 14, 2025, at 12:20 p.m. ET [1]