Vericel (VCEL)
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Vericel (VCEL) - 2025 Q2 - Quarterly Report
2025-07-31 12:50
[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Unaudited financial statements for Q2 2025 show total revenues of **$63.2 million** and **$115.8 million** for the six-month period, with a net loss of **$0.55 million** for the quarter [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased slightly to **$435.6 million**, total liabilities decreased to **$128.8 million**, and shareholders' equity grew to **$306.8 million** Balance Sheet Summary (in thousands) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $80,532 | $74,520 | | Total current assets | $204,577 | $212,777 | | Total assets | $435,608 | $432,722 | | **Liabilities & Equity** | | | | Total current liabilities | $41,132 | $50,286 | | Total liabilities | $128,799 | $140,755 | | Total shareholders' equity | $306,809 | $291,967 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2025 total revenue increased **20.1%** to **$63.2 million**, with gross profit up **27.4%**, significantly narrowing net loss to **$0.55 million** from **$4.7 million** in Q2 2024 Q2 2025 vs Q2 2024 Statement of Operations (in thousands) | Metric | Q2 2025 | Q2 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Total revenue | $63,240 | $52,662 | +20.1% | | Gross profit | $46,613 | $36,601 | +27.4% | | Total operating expenses | $48,642 | $42,632 | +14.1% | | Loss from operations | ($2,029) | ($6,031) | +66.4% | | Net loss | ($553) | ($4,682) | +88.2% | | Net loss per share | ($0.01) | ($0.10) | +90.0% | Six Months 2025 vs 2024 Statement of Operations (in thousands) | Metric | H1 2025 | H1 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Total revenue | $115,838 | $103,943 | +11.4% | | Gross profit | $82,886 | $71,955 | +15.2% | | Total operating expenses | $97,707 | $83,450 | +17.1% | | Loss from operations | ($14,821) | ($11,495) | -28.9% | | Net loss | ($11,799) | ($8,544) | -38.1% | | Net loss per share | ($0.24) | ($0.18) | -33.3% | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities for H1 2025 was **$14.8 million**, with net cash used in investing activities at **$24.2 million**, resulting in a **$4.5 million** decrease in total cash Six-Month Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $14,814 | $25,737 | | Net cash used in investing activities | ($24,170) | ($43,171) | | Net cash provided by financing activities | $4,839 | $6,422 | | **Net decrease in cash** | **($4,517)** | **($11,012)** | - Expenditures for property and equipment were **$22.3 million** for the first six months of **2025**, compared to **$30.8 million** in the same period of **2024**[17](index=17&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's products (**MACI**, **Epicel**, **NexoBrid**), revenue breakdown by product, and confirm sufficient liquidity for the next **12 months** - The company markets three products: **MACI** (cartilage repair), **Epicel** (severe burn care), and **NexoBrid** (eschar removal in burn patients)[20](index=20&type=chunk)[21](index=21&type=chunk) - In August **2024**, the **FDA** approved **MACI Arthro™**, allowing for arthroscopic delivery of the **MACI** implant, which became commercially available in Q3 **2024**[20](index=20&type=chunk) Revenue by Product (in thousands) | Product | Q2 2025 | Q2 2024 | Change (%) | H1 2025 | H1 2024 | Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | MACI | $53,458 | $44,135 | +21.1% | $99,755 | $84,316 | +18.3% | | Epicel | $8,614 | $7,758 | +11.0% | $13,578 | $18,422 | -26.3% | | NexoBrid | $1,168 | $769 | +51.9% | $2,505 | $1,205 | +107.9% | | **Total** | **$63,240** | **$52,662** | **+20.1%** | **$115,838** | **$103,943** | **+11.4%** | - The company has a **$150.0 million** five-year senior secured revolving credit agreement, with no outstanding borrowings as of June **30**, **2025**[60](index=60&type=chunk)[62](index=62&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes Q2 revenue growth to increased **MACI** volume and price, alongside **Epicel** and **NexoBrid** growth, and confirms sufficient liquidity for the next **12 months** [Overview](index=21&type=section&id=Overview) **Vericel** is a biopharmaceutical company focused on sports medicine and severe burn care, with **MACI Arthro™** expected to drive growth by expanding the target surgeon base - The company believes the availability of **MACI Arthro** provides a significant growth opportunity and has expanded its target surgeon base from **5,000** to **7,000**[94](index=94&type=chunk) - **Vericel** plans to initiate a clinical trial for **MACI** use in the ankle beginning in **2025**, which it views as a significant long-term growth driver[94](index=94&type=chunk) - The company is monitoring the conflict in the Middle East as its supplier for **NexoBrid**, **MediWound**, has manufacturing facilities in Israel, but does not currently anticipate a material disruption to supply[84](index=84&type=chunk)[85](index=85&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q2 **2025** total revenue increased **20.1%** to **$63.2 million**, driven by **MACI**, **Epicel**, and **NexoBrid** growth, while SG&A expenses rose due to headcount and marketing Q2 2025 vs Q2 2024 Revenue by Product (in thousands) | Product | Q2 2025 | Q2 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | MACI | $53,458 | $44,135 | $9,323 | 21.1% | | Epicel | $8,614 | $7,758 | $856 | 11.0% | | NexoBrid | $1,168 | $769 | $399 | 51.9% | | **Total** | **$63,240** | **$52,662** | **$10,578** | **20.1%** | - The increase in SG&A expenses for Q2 and H1 **2025** was primarily due to higher headcount and employee expenses, increased marketing programs, and facility costs for the new **Burlington** facility[107](index=107&type=chunk)[108](index=108&type=chunk) - R&D expenses decreased in Q2 **2025** compared to Q2 **2024**, mainly due to higher costs related to the **MACI Arthro** project in **2024**[105](index=105&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) As of June **30**, **2025**, the company had **$80.5 million** in cash and **$83.7 million** in investments, with management confirming sufficient liquidity for at least the next **12 months** - The company had **$80.5 million** in cash and cash equivalents, plus **$83.7 million** in investments as of June **30**, **2025**[112](index=112&type=chunk) - Management believes current cash, investments, and available borrowing capacity will be sufficient to support operations for at least **12 months** from the report's issuance[119](index=119&type=chunk) - The company has a **$150.0 million** five-year senior secured revolving credit agreement available for working capital and general corporate purposes, with no outstanding borrowings[121](index=121&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that its exposures to market risk have not changed materially since December **31**, **2024** - There have been no material changes in the company's market risk exposures since the end of the last fiscal year[126](index=126&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June **30**, **2025**, with no material changes in internal control over financial reporting - The company's Certifying Officers concluded that disclosure controls and procedures were effective as of June **30**, **2025**[127](index=127&type=chunk) - No material changes were made to the company's internal control over financial reporting during the second quarter of **2025**[129](index=129&type=chunk) [PART II — OTHER INFORMATION](index=29&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - As of the filing date, **Vericel** is not involved in any material legal proceedings[130](index=130&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company highlights a specific risk related to potential disruptions at the **FDA** due to inadequate funding and personnel changes, which could delay regulatory approvals - The company identifies a risk that inadequate funding and potential disruptions at the **FDA** could delay the review and approval of new products or product changes[132](index=132&type=chunk) - Potential disruptions at the **FDA** could specifically impact the review of submissions for the **MACI** Ankle clinical trial, for which enrollment is expected to begin in the second half of **2025**[133](index=133&type=chunk) - The change in presidential administration in **2025** creates uncertainty regarding **FDA** policies and regulations, which could prevent, limit, or delay regulatory approvals[135](index=135&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) Three Section **16** officers or directors adopted **Rule 10b5-1** trading plans for the potential sale of company common stock during Q2 **2025** - Three insiders adopted **Rule 10b5-1** trading plans during the quarter ended June **30**, **2025**: - **Kevin McLaughlin** (Director): Potential sale of up to **35,000** shares - **Robert Zerbe** (Chairman): Potential sale of up to **7,500** shares - **Jonathan Hopper** (CMO): Potential sale of up to **37,847** shares[139](index=139&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form **10-Q**, including certifications by the CEO and CFO
Vericel (VCEL) - 2025 Q2 - Earnings Call Presentation
2025-07-31 12:30
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]
Vericel (VCEL) - 2025 Q2 - Quarterly Results
2025-07-31 12:14
Q2 2025 Performance Overview [Financial Highlights](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) The company reported strong Q2 2025 results with 20% revenue growth, significant margin expansion, and a 112% surge in adjusted EBITDA Financial Highlights | Metric | Q2 2025 | Growth vs. Q2 2024 | | :--- | :--- | :--- | | **Total Net Revenue** | $63.2 million | +20% | | **MACI Net Revenue** | $53.5 million | +21% | | **Burn Care Net Revenue** | $9.8 million | - | | - Epicel Revenue | $8.6 million | - | | - NexoBrid Revenue | $1.2 million | - | | **Gross Margin** | 74% | +400 bps | | **Net Loss** | ($0.6) million | Improved from ($4.7) million | | **Adjusted EBITDA** | $13.4 million | +112% | | **Adjusted EBITDA Margin** | 21% | +900 bps | - The company ended the quarter with a strong balance sheet, holding approximately **$164 million in cash and investments with no debt**[3](index=3&type=chunk)[12](index=12&type=chunk) - Operating cash flow for the second quarter was **$8.2 million**[3](index=3&type=chunk) [Business Highlights and Updates](index=2&type=section&id=Business%20Highlights%20and%20Updates) The company achieved key operational milestones, including FDA clearance for a new study and strong adoption across its product lines - Received **FDA Investigational New Drug (IND) clearance** for the MACI Ankle™ clinical study, which is on track to begin in the second half of 2025[2](index=2&type=chunk)[8](index=8&type=chunk) - Approximately **600 MACI Arthro™ surgeons have been trained** to date, indicating strong adoption[2](index=2&type=chunk)[8](index=8&type=chunk) - The company recorded the **second-highest number of MACI biopsies** in a quarter since launch and the highest number of Epicel biopsies since 2023[8](index=8&type=chunk) - NexoBrid revenue **increased 52% versus the prior year**, and June saw the highest number of hospital unit orders since launch[8](index=8&type=chunk) [2025 Financial Guidance](index=2&type=section&id=2025%20Financial%20Guidance) The company reaffirmed its full-year 2025 revenue growth and profitability targets while updating its Burn Care revenue guidance Full Year 2025 Outlook | Guidance Metric | Full Year 2025 Outlook | | :--- | :--- | | **MACI Revenue Growth** | Reaffirmed in the low 20% range | | **Burn Care Revenue (H2 2025)** | Updated to approx. $10 million per quarter | | **Gross Margin** | Reaffirmed at 74% | | **Adjusted EBITDA Margin** | Reaffirmed at 26% | Detailed Financial Statements [Consolidated Statements of Operations](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) The company's Q2 2025 revenue grew to $63.2 million, driving a significant reduction in net loss despite higher operating expenses Condensed Consolidated Statements of Operations | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Total revenue** | $63,240 | $52,662 | | **Gross profit** | $46,613 | $36,601 | | **Total operating expenses** | $48,642 | $42,632 | | **Loss from operations** | ($2,029) | ($6,031) | | **Net loss** | ($553) | ($4,682) | | **Net loss per share** | ($0.01) | ($0.10) | - The increase in operating expenses was primarily driven by increased headcount, related employee expenses, and costs associated with the new Burlington facility, including depreciation and MACI tech transfer activities[10](index=10&type=chunk) [GAAP vs. Non-GAAP Reconciliation](index=7&type=section&id=RECONCILIATION%20OF%20REPORTED%20NET%20LOSS%20(GAAP)%20TO%20ADJUSTED%20EBITDA%20(NON-GAAP%20MEASURE)) Non-GAAP adjusted EBITDA increased to $13.4 million, with key adjustments including stock-based compensation and depreciation Reconciliation of Reported Net Loss (GAAP) to Adjusted EBITDA (Non-GAAP) | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Net loss (GAAP)** | ($553) | ($4,682) | | Stock-based compensation | $10,140 | $9,520 | | Depreciation and amortization | $2,826 | $1,323 | | Pre-occupancy lease & tech transfer | $2,446 | $1,509 | | **Adjusted EBITDA (Non-GAAP)** | **$13,359** | **$6,313** | [Condensed Consolidated Balance Sheets](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) The company maintained a strong balance sheet with $435.6 million in total assets and a robust liquidity position Condensed Consolidated Balance Sheets | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash, cash equivalents & investments** | $164,281 | $156,093 | | **Total current assets** | $204,577 | $212,777 | | **Total assets** | $435,608 | $432,722 | | **Total current liabilities** | $41,132 | $50,286 | | **Total liabilities** | $128,799 | $140,755 | | **Total shareholders' equity** | $306,809 | $291,967 | Other Information [About Vericel Corporation](index=3&type=section&id=About%20Vericel%20Corporation) The company provides advanced therapies for sports medicine and severe burn care, with three key products marketed in the U.S - Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets[15](index=15&type=chunk) - The company markets three products in the United States: **MACI®** (for knee cartilage defects), **Epicel®** (for severe burns), and **NexoBrid®** (for eschar removal in thermal burns)[15](index=15&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines potential risks and uncertainties that could cause actual results to differ from forward-looking statements - The company identifies several risk factors that could cause actual results to differ from forward-looking statements[18](index=18&type=chunk) - Key risks include uncertainties in future revenue, market penetration for products like MACI and NexoBrid, ability to scale manufacturing (including the new Burlington facility), and potential supply chain disruptions[19](index=19&type=chunk)[20](index=20&type=chunk)
Vericel Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-07-31 12:08
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]
Vericel to Report Second-Quarter 2025 Financial Results on July 31, 2025
Globenewswire· 2025-07-17 12:30
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]
Vericel (VCEL) Earnings Call Presentation
2025-07-11 08:25
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]
Vericel (VCEL) - 2018 Q4 - Earnings Call Presentation
2025-07-03 13:09
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]
Vericel (VCEL) - 2019 Q4 - Earnings Call Presentation
2025-07-03 13:08
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]
Vericel (VCEL) - 2021 Q4 - Earnings Call Presentation
2022-02-24 18:26
VERICEL Q4 2021 RESULTS FEBRUARY 24, 2022 Safe Harbor | --- | --- | --- ...
Vericel (VCEL) 2025 Conference Transcript
2025-06-17 14:22
Summary of Vericel Conference Call Company Overview - Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care market [3] - The company has a portfolio of advanced cell therapies and specialty biologics designed to restore or repair damaged tissue [4] Key Products - **MACI**: An advanced cell therapy for repairing damaged cartilage, launched in 2017, now the leading restorative biologic cartilage repair product [4] - Received FDA approval for label expansion for arthroscopic delivery of MACI for defects up to four square centimeters [4] - **NexoBrid**: An orphan biologic product for the removal of burn tissue in patients [5] - **Epicel**: The only FDA-approved permanent skin replacement for patients with large, full-thickness burns [5] Competitive Advantages - Unique FDA-approved products with strong competitive barriers to entry [6] - MACI and Epicel are regulated as combination device biologic products, limiting competition [6] - NexoBrid has seven years of orphan market exclusivity and twelve years of biologic data exclusivity [7] Financial Performance - 20% compound annual revenue growth since MACI's launch in 2017 [8] - Ended last year with a 73% gross margin, up almost 400 basis points from 2023 [8] - Consistent positive adjusted EBITDA and operating cash flow for the last five years [8] - Strong balance sheet with approximately $160 million in cash [9] Growth Drivers for MACI - Expansion of the surgeon base and increasing the number of biopsies per surgeon [15] - High reimbursement rates, with over 90% approval for treatment by insurance companies [13] - Continued growth expected from MACI Arthro, targeting smaller defects in the knee [19][22] MACI Arthro Launch - MACI Arthro is seen as both a deeper and broader strategy for growth [19] - Surgeons trained for MACI Arthro increased from 150 to 400 within a few months [25] - Biopsy growth rate for trained surgeons was up 30%, indicating strong early adoption [26] - The product is designed for smaller defects, expanding the addressable market significantly [22] Guidance and Market Outlook - Increased financial guidance due to strong performance and market conditions [39] - Epicel's growth was 16% last year, with expectations for normalization in future quarters [41] - Anticipated significant cash generation post-capital expenditures [44] Capital Allocation - Focus on business development opportunities while maintaining a disciplined approach [47] - Expectation of increased free cash flow as capital expenditures decrease [44] Conclusion - Vericel is positioned for continued growth with a strong product portfolio, competitive advantages, and a solid financial foundation, particularly with the launch of MACI Arthro and ongoing market expansion efforts [49]