Core Insights - The FDA has approved Vericel Corporation's MACI® for arthroscopic delivery, targeting the $3 billion addressable market for cartilage repair [1][2] - MACI Arthro offers a less invasive technique for repairing knee cartilage defects, potentially increasing market penetration and revenue growth for the company [2][3] Company Overview - Vericel Corporation specializes in advanced therapies for sports medicine and severe burn care, with a focus on innovative cell therapies and specialty biologics [6] - The company markets three main products: MACI, Epicel®, and holds rights to NexoBrid® [6] Product Details - MACI is the first FDA-approved cellularized scaffold product for repairing full-thickness cartilage defects in the knee, utilizing the patient's own cartilage cells [2][3] - The new MACI Arthro technique allows for treatment of defects up to 4 cm², specifically targeting the most common defects in the market [2][3] Market Potential - The MACI addressable market includes approximately 20,000 patients annually, representing one-third of the total market [2] - The company plans to expand its target surgeon base from 5,000 to 7,000, focusing on those performing high volumes of cartilage repair surgeries [2]

Core Insights - The FDA has approved NexoBrid for pediatric use, expanding its target customer base to approximately 20 pediatric burn centers in the U.S. [1][2] - NexoBrid is positioned as a novel non-surgical solution for managing severe burn injuries in pediatric patients, potentially becoming the new standard of care [2][3] - The approval is based on the results of the global Phase 3 clinical trial, Children Innovation Debridement Study (CIDS), which assessed the safety and efficacy of NexoBrid in hospitalized pediatric patients [2] Company Overview - Vericel Corporation is a leader in advanced therapies for sports medicine and severe burn care markets, with a differentiated portfolio of innovative cell therapies and specialty biologics [7] - The company markets three products in the U.S.: MACI, Epicel, and NexoBrid, the latter being a biological orphan product indicated for eschar removal in both adults and pediatric patients [7] - NexoBrid was initially approved for adult use on December 28, 2022, and is now commercially available in the U.S. [4] Product Information - NexoBrid (anacaulase-bcdb) is indicated for eschar removal in patients with deep partial-thickness and/or full-thickness thermal burns [5] - The product contains proteolytic enzymes and offers a less invasive alternative to traditional burn treatment methods [3][5] - Limitations of use include contraindications for certain types of burns and specific patient conditions [5][6]

Group 1 - Vericel Corporation is a leader in advanced therapies for sports medicine and severe burn care markets [2] - The company will have a presentation at the Canaccord Genuity Growth Conference on August 14, 2024, at 3:00 p.m. ET [1] - A webcast of the presentation will be available on the Investor Relations section of the Vericel Corporation website [1] Group 2 - Vericel markets three main products in the United States: MACI®, Epicel®, and holds an exclusive license for NexoBrid® [2] - MACI® is indicated for the repair of full-thickness cartilage defects of the knee in adults [2] - Epicel® serves as a permanent skin replacement for patients with significant burns [2] - NexoBrid® is indicated for the removal of eschar in adults with deep partial-thickness and/or full-thickness burns [2]

CAMBRIDGE, Mass., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, President and CEO, will present at the Canaccord Genuity Growth Conference at 3:00 p.m. ET on Wednesday, August 14, 2024. 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 ...

Financial Data and Key Metrics Changes - The company reported record second quarter revenue of nearly $53 million, representing a 20% growth in total revenue for the first half of the year [7][16] - Gross margin reached 70%, an increase of 430 basis points compared to the prior year, marking the highest second quarter gross margin to date [17] - Adjusted EBITDA grew by 42% year-over-year, reaching $6.3 million or 12% of net revenue [18] - The company generated $18.5 million of operating cash flow in the quarter and ended with $154 million in cash, restricted cash, and investments, with no debt [18] Business Line Data and Key Metrics Changes - MACI revenue was over $44 million, increasing 21% year-over-year and exceeding guidance [8][16] - Burn Care revenue totaled $8.5 million, with NexoBrid revenue increasing 76% compared to the prior quarter [16] - Epicel revenue remained stable at approximately $8 million, with a quarterly run rate increasing to over $9 million for the first half of the year [13][18] Market Data and Key Metrics Changes - The company is expanding its target surgeon base for MACI from 5,000 to 7,000 surgeons with the upcoming launch of MACI Arthro [10] - Approximately 70 burn centers completed P&T Committee submissions for NexoBrid, with over 40 centers gaining approval [12] Company Strategy and Development Direction - The company is focused on launching MACI Arthro to expand its market reach, targeting smaller cartilage defects [10] - Plans are in place to initiate the MACI Ankle clinical study in 2025, representing a significant growth opportunity with an estimated $1 billion addressable market [11] - The company is actively pursuing business development opportunities in sports medicine and advanced cell therapy [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued high revenue and profit growth for the remainder of the year, reaffirming revenue guidance of $238 million to $242 million [19][50] - The company expects to be GAAP profitable in 2024 and anticipates strong growth in both MACI and Burn Care revenue for the third quarter [20][19] Other Important Information - The company is preparing for the FDA approval of a pediatric indication for NexoBrid, which is expected to enhance uptake in pediatric burn centers [12][40] - The company has implemented a sales force optimization plan, increasing territories for the Burn Care sales force to 17 [28] Q&A Session Summary Question: Clarification on MACI pacing expectations and conversion rates - Management confirmed strong performance in MACI and expects continued growth, with Q3 estimates around $44.5 million [22][23] - Conversion rates are expected to improve as surgeons gain experience, with no anticipated negative impact from targeting smaller cartilage defects [25][26] Question: Inquiry about Burn Care market stability - Management reassured that there are no structural changes in the burn market, citing consistent biopsy numbers and strong growth indicators for Epicel [27][28] Question: Record number of biopsies in May - Management confirmed that the highest number of biopsies occurred in May, independent of the upcoming arthroscopic launch [30] Question: Update on business development initiatives - Management stated that they are actively seeking synergistic opportunities in sports medicine and advanced cell therapy, maintaining a high bar for potential acquisitions [36][37] Question: Composition of Burn Care revenue in Q3 - Management indicated that Epicel is expected to maintain a higher run rate, while NexoBrid is also progressing positively [42][43] Question: Pediatric indication for NexoBrid and its impact - Management highlighted that approximately 20 pediatric burn centers will be added to the target customer base upon approval, which is expected to significantly impact NexoBrid uptake [48][40]

Vericel Corporation (VCEL) came out with a quarterly loss of $0.10 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.11 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this company would post a loss of $0.11 per share when it actually produced a loss of $0.08, delivering a surprise of 27.27%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Vericel, which belongs to the Zac ...

Core Insights - Vericel Corporation reported total revenue of $52.7 million for Q2 2024, marking a 15% increase from $45.9 million in Q2 2023, with MACI revenue growing by 21% to $44.1 million [2][5] - The company raised its full-year profitability guidance to a gross margin of 71% and an adjusted EBITDA margin of 21% [5][4] - NexoBrid revenue saw significant growth of 76% over the prior quarter, contributing to the overall positive financial performance [1][4] Financial Highlights - Total net revenue for Q2 2024 was $52.7 million, with MACI net revenue at $44.1 million and Burn Care net revenue at $8.5 million [2][5] - Gross margin improved to 70%, an increase of 430 basis points compared to the previous year [2][6] - Non-GAAP adjusted EBITDA increased by 42% to $6.3 million, representing an adjusted EBITDA margin of 12% [2][8] Business Updates - The second quarter saw record total revenue and MACI revenue, alongside the second highest number of MACI biopsies since launch [4] - The company is progressing with commercial plans for MACI Arthro™ and has made significant strides in the launch of NexoBrid, with over 40 burn centers placing initial orders [4] - FDA approval for a pediatric indication for NexoBrid is anticipated in Q3 2024 [4] Cash Position - As of June 30, 2024, Vericel had approximately $154 million in cash, restricted cash, and investments, with no debt [9]

CAMBRIDGE, Mass., July 22, 2024 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the appointment of Karen Mahoney as Chief Human Resources Officer following the retirement of Heidi Hassen, who served as Vericel's Head of Human Resources since September 2010. "I am delighted to welcome Karen to Vericel," said Nick Colangelo, President and CEO of Vericel. "Karen has a strong track record of building high ...

Core Points - Vericel Corporation, a leader in advanced therapies for sports medicine and severe burn care, will report its second-quarter 2024 financial results on August 1, 2024 [2] - The management will host a conference call and webcast at 8:30 a.m. (ET) to discuss financial results and business highlights [2] Company Overview - Vericel is a leading provider of advanced therapies, combining innovations in biology with medical technologies to create a differentiated portfolio of cell therapies and specialty biologics [5] - The company markets three products in the United States: - MACI® for repairing full-thickness cartilage defects of the knee [5] - Epicel® as a permanent skin replacement for deep dermal or full-thickness burns [5] - NexoBrid®, licensed for North American rights, indicated for the removal of eschar in burn patients [5]

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 | --- | |-------------------| | | | Investor Contact: | | Eric Burns | | ir@vcel.com | | +1 (734) 418-4411 | | Media Contact: | | Julie Downs | | media@vcel.com | CAMBRIDGE, Mass., June 11, 2024 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, tod ...