Core Insights - MannKind Corporation reported strong revenue growth in Q3 2024, indicating a positive performance for the company [5]. Group 1: Company Overview - The conference call featured key participants including Eric Burns (Vice President of Finance & Investor Relations), Nick Colangelo (Chief Executive Officer), and Joe Mara (Chief Financial Officer) [1][2][3]. - The company emphasized the importance of forward-looking statements and the associated risks and uncertainties [4][5]. Group 2: Financial Performance - The company highlighted its outstanding quarter with significant total revenue growth, showcasing its operational success [5].

Company Performance - Vericel Corporation reported a quarterly loss of $0.02 per share, better than the Zacks Consensus Estimate of a loss of $0.05, and an improvement from a loss of $0.08 per share a year ago, representing an earnings surprise of 60% [1] - The company posted revenues of $57.91 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 4.68%, and showing an increase from year-ago revenues of $45.58 million [2] - Over the last four quarters, Vericel has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2] Stock Performance - Vericel shares have increased approximately 34.9% since the beginning of the year, outperforming the S&P 500's gain of 24.3% [3] - The current consensus EPS estimate for the coming quarter is $0.33 on revenues of $81.48 million, and for the current fiscal year, it is $0.12 on revenues of $240.74 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Vericel belongs, is currently in the top 36% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that industry performance can significantly impact stock performance [5][8]

Financial Performance - Q3 2024 - Record Q3 total revenue reached $57.9 million[3] - MACI revenue experienced a growth of 19% reaching $44.7 million[3] - Burn Care revenue increased by 66% reaching $13.2 million[3] - Gross margin improved to 72%, a 480 bps increase compared to Q3 2023[3] - Adjusted EBITDA increased by 84% reaching $10.0 million compared to Q3 2023[3] Financial Performance - Year-to-Date (YTD) 2024 - Total net revenue increased by 22% to $161.8 million[4] - MACI net revenue grew by 19% to $129.0 million[4] - Burn Care net revenue increased by 35% to $32.9 million[4] - Adjusted EBITDA growth of 103% to $23.6 million, with a 15% adjusted EBITDA margin, up 580 bps vs prior year[4] Financial Guidance - The company anticipates total revenue between $238 million and $242 million[8] - The company raised guidance to 72% gross margin[9] - The company raised guidance to 22% Adjusted EBITDA Margin[9]

Core Insights - Vericel Corporation reported a total revenue growth of 27% to $57.9 million for the third quarter of 2024, compared to $45.6 million in the same period of 2023 [5][2] - The company achieved a gross margin of 72%, an increase of 480 basis points year-over-year, and a significant adjusted EBITDA growth of 84% to $10.0 million [2][6] - Full-year profitability guidance has been raised, with expectations of a gross margin of 72% and an adjusted EBITDA margin of 22% [5] Financial Highlights - Total net revenue for Q3 2024 was $57.9 million, with MACI® net revenue growing 19% to $44.7 million and Burn Care net revenue increasing 66% to $13.2 million [2][5] - Year-to-date total net revenue increased 22% to $161.8 million, with MACI net revenue growth of 19% to $129.0 million and Burn Care net revenue growth of 35% to $32.9 million [3] - The company reported a net loss of $0.9 million, or $0.02 per diluted share, compared to a net loss of $3.7 million, or $0.08 per diluted share, in Q3 2023 [7][2] Business Developments - Vericel achieved record highs in total revenue, MACI revenue, and Epicel revenue for the third quarter [4] - The FDA approved MACI Arthro™ for repairing symptomatic cartilage defects in the knee, and a pediatric indication for NexoBrid was also approved [4] - The company is on track to submit MACI Ankle™ IND in the first half of 2025 and expects to initiate clinical studies in the second half of 2025 [4] Cash Position - As of September 30, 2024, Vericel had approximately $151 million in cash, restricted cash, and investments, with no debt [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] Product Portfolio - The company 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 patients with 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] Upcoming Events - Nick Colangelo, President and CEO, and Joe Mara, CFO, will participate in a fireside chat at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 6, 2024, at 1:05 p.m. ET [1]

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]