Vericel Reports Third Quarter 2024 Financial Results
Vericel (NASDAQ:VCEL) reported strong Q3 2024 financial results with total revenue increasing 27% to $57.9 million. The company achieved record quarterly revenues, with MACI net revenue growing 19% to $44.7 million and Burn Care revenue rising 66% to $13.2 million. Gross margin improved to 72%, and adjusted EBITDA increased 84% to $10.0 million. The quarter saw FDA approvals for MACI Arthro and NexoBrid pediatric indication. The company maintained its 2024 revenue guidance of $238-242 million while raising profitability guidance to 72% gross margin and 22% adjusted EBITDA margin.
Vericel (NASDAQ:VCEL) ha riportato risultati finanziari forti per il terzo trimestre del 2024, con un aumento del 27% del fatturato totale che ha raggiunto 57,9 milioni di dollari. L'azienda ha raggiunto ricavi trimestrali record, con ricavi netti da MACI in aumento del 19% a 44,7 milioni di dollari e ricavi da Burn Care in crescita del 66% a 13,2 milioni di dollari. Il margine lordo è migliorato al 72% e l'EBITDA rettificato è aumentato dell'84% a 10,0 milioni di dollari. Durante il trimestre, ci sono state approvazioni dalla FDA per l'indicazione pediatrica di MACI Arthro e NexoBrid. L'azienda ha mantenuto le previsioni di fatturato per il 2024 tra 238-242 milioni di dollari, alzando però le previsioni di redditività a un margine lordo del 72% e un margine EBITDA rettificato del 22%.
Vericel (NASDAQ:VCEL) reportó resultados financieros sólidos para el tercer trimestre de 2024, con un aumento del 27% en los ingresos totales, alcanzando 57.9 millones de dólares. La compañía logró ingresos trimestrales récord, con ingresos netos de MACI creciendo un 19% a 44.7 millones de dólares y los ingresos por Burn Care aumentando un 66% a 13.2 millones de dólares. El margen bruto mejoró al 72% y el EBITDA ajustado aumentó un 84% a 10.0 millones de dólares. Durante el trimestre se aprobaron por parte de la FDA las indicaciones pediátricas de MACI Arthro y NexoBrid. La compañía mantuvo su guía de ingresos para 2024 entre 238-242 millones de dólares mientras elevó la guía de rentabilidad al 72% de margen bruto y al 22% de margen EBITDA ajustado.
Vericel (NASDAQ:VCEL)는 2024년 3분기 강력한 재무 결과를 보고했으며, 총 수익이 27% 증가하여 5,790만 달러에 달했습니다. 이 회사는 분기별 수익을 기록하며, MACI 순 수익이 19% 증가하여 4,470만 달러에 이르고 Burn Care 수익이 66% 증가하여 1,320만 달러에 도달했습니다. 총 마진은 72%로 개선되었으며, 조정 EBITDA는 84% 증가하여 1,000만 달러에 달했습니다. 이번 분기에는 MACI Arthro와 NexoBrid의 소아 적응증에 대한 FDA 승인이 있었습니다. 이 회사는 2024년 수익 전망을 2억3800만~2억4200만 달러로 유지하며, 수익성 전망을 72% 총 마진 및 22% 조정 EBITDA 마진으로 상향 조정했습니다.
Vericel (NASDAQ:VCEL) a annoncé des résultats financiers solides pour le troisième trimestre 2024, avec une augmentation de 27 % des revenus totaux, atteignant 57,9 millions de dollars. L'entreprise a réalisé des revenus trimestriels records, avec des revenus nets de MACI en hausse de 19 % à 44,7 millions de dollars et des revenus de Burn Care en augmentation de 66 % à 13,2 millions de dollars. La marge brute s'est améliorée à 72%, et l'EBITDA ajusté a augmenté de 84% à 10,0 millions de dollars. Au cours du trimestre, des approbations de la FDA ont été obtenues pour l'indication pédiatrique de MACI Arthro et NexoBrid. L'entreprise a maintenu ses prévisions de revenus pour 2024 entre 238 et 242 millions de dollars tout en augmentant les prévisions de rentabilité à une marge brute de 72 % et une marge EBITDA ajustée de 22 %.
Vericel (NASDAQ:VCEL) hat starke Finanzresultate für das dritte Quartal 2024 veröffentlicht, mit einem Anstieg der Gesamterlöse um 27% auf 57,9 Millionen Dollar. Das Unternehmen erzielte Rekordumsätze im Quartal, wobei die Nettoumsätze aus MACI um 19% auf 44,7 Millionen Dollar stiegen und die Erlöse aus Burn Care um 66% auf 13,2 Millionen Dollar zulegten. Die Bruttomarge verbesserte sich auf 72%, und das bereinigte EBITDA stieg um 84% auf 10,0 Millionen Dollar. Im Laufe des Quartals erhielt die FDA Genehmigungen für die pädiatrische Indikation von MACI Arthro und NexoBrid. Das Unternehmen hielt seine Umsatzprognose für 2024 von 238-242 Millionen Dollar aufrecht und erhöhte die Prognose für die Rentabilität auf eine Bruttomarge von 72% und eine bereinigte EBITDA-Marge von 22%.
- Total revenue growth of 27% to $57.9 million in Q3 2024
- Gross margin improvement to 72%, up 480 basis points
- 84% increase in adjusted EBITDA to $10.0 million
- Strong cash position of $151 million with no debt
- FDA approval of MACI Arthro and NexoBrid pediatric indication
- Raised profitability guidance for 2024
- Net loss of $0.9 million ($0.02 per diluted share) in Q3 2024
- Operating expenses increased to $44.1 million from $35.7 million
Insights
Strong quarterly performance with
The company's financial health is robust with
The FDA approval of MACI Arthro for knee cartilage defects up to 4 cm² represents a significant market expansion opportunity. The arthroscopic delivery system could improve procedure efficiency and patient outcomes. The planned MACI Ankle IND submission shows pipeline progression, while NexoBrid's pediatric indication approval expands the addressable market in burn care.
The strong adoption metrics, including record MACI biopsies and surgeon engagement, coupled with NexoBrid's successful P&T committee approvals at approximately 50 burn centers, demonstrate growing market penetration and physician acceptance of the company's advanced therapy portfolio.
Total Revenue Growth of
Gross Margin of
Full-Year Profitability Guidance Raised
FDA Approval and Commercial Launch of MACI Arthro in Third Quarter
Conference Call Today at 8:30am Eastern Time
CAMBRIDGE, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today reported financial results and business highlights for the third quarter ended September 30, 2024.
Third Quarter 2024 Financial Highlights
- Total net revenue of
$57.9 million - MACI® net revenue growth of
19% to$44.7 million - Burn Care net revenue growth of
66% to$13.2 million , consisting of$12.2 million of Epicel® revenue and$1.1 million of NexoBrid® revenue - Gross margin of
72% , an increase of 480 basis points versus the prior year - Net loss of
$0.9 million , or$0.02 per diluted share - Non-GAAP adjusted EBITDA increased
84% to$10.0 million , representing adjusted EBITDA margin of17% , an increase of 540 basis points versus the prior year - Operating cash flow of
$10.2 million - As of September 30, 2024, the Company had approximately
$151 million in cash, restricted cash and investments, and no debt
Year to Date 2024 Financial Highlights
- Total net revenue increased
22% to$161.8 million - MACI net revenue growth of
19% to$129.0 million - Burn Care net revenue growth of
35% to$32.9 million - Gross margin of
70% , an increase of 450 basis points versus the prior year - Net loss of
$9.4 million , or$0.19 per diluted share - Non-GAAP adjusted EBITDA increased
103% to$23.6 million , representing adjusted EBITDA margin of15% , an increase of 580 basis points versus the prior year - Operating cash flow of
$36 million
Business Highlights and Updates
- Record third quarter total revenue and MACI revenue, and the highest quarterly Epicel revenue to date
- Record third quarter highs for MACI biopsies and the number of surgeons taking biopsies
- More than 70 NexoBrid Pharmacy and Therapeutics (P&T) committee submissions, with approximately 50 burn centers obtaining P&T committee approval and placing initial orders
- Announced FDA approval of MACI Arthro™ to repair symptomatic single or multiple full-thickness cartilage defects of the knee up to 4 cm2 using Vericel’s custom-designed arthroscopic delivery instruments
- On track to submit MACI Ankle™ IND in the first half of 2025 and expect to initiate clinical study in second half of 2025
- Announced FDA approval of a pediatric indication for NexoBrid for eschar removal in pediatric patients with deep partial-thickness and/or full-thickness thermal burns
“The Company had another excellent quarter as we generated strong revenue and profitability growth and achieved two important regulatory milestones with the FDA approval of MACI Arthro and a NexoBrid pediatric indication,” said Nick Colangelo, President and CEO of Vericel. “We believe that the Company is very well-positioned to deliver a strong close to the year and to deliver a unique combination of sustained high revenue and profit growth in 2025 and beyond based on the strength of our core portfolio, the recent launch of MACI Arthro and the continued progress on other long-term growth initiatives.”
2024 Financial Guidance
- Maintained total net revenue guidance of
$238 t o$242 million , or20% to23% growth - Profitability guidance raised to
72% gross margin and22% adjusted EBITDA margin, compared to the previous guidance of71% and21% , respectively
Third Quarter 2024 Results
Total net revenue for the quarter ended September 30, 2024 increased
Gross profit for the quarter ended September 30, 2024 was
Total operating expenses for the quarter ended September 30, 2024 were
Net loss for the quarter ended September 30, 2024 was
Non-GAAP adjusted EBITDA for the quarter ended September 30, 2024 was
As of September 30, 2024, the Company had approximately
Conference Call Information
Today’s conference call will be available live at 8:30 a.m. Eastern Time and can be accessed through the Investor Relations section of the Vericel website at http://investors.vcel.com/events-presentations. A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software, if necessary. To participate by telephone, please register here to receive dial-in details and your personal passcode. A replay of the webcast will be available on the Vericel website until November 7, 2025.
About Vericel Corporation
Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets. The Company combines innovations in biology with medical technologies, resulting in a highly differentiated portfolio of innovative cell therapies and specialty biologics that repair injuries and restore lives. Vericel markets three products in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to
GAAP v. Non-GAAP Measures
Vericel’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. Vericel has provided in this release certain financial information that has not been prepared in accordance with GAAP. Vericel’s management believes that the non-GAAP adjusted EBITDA described in this release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding Vericel’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in Vericel’s industry. However, the non-GAAP financial measures that Vericel uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP.
Epicel® and MACI® are registered trademarks of Vericel Corporation. NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2024 Vericel Corporation. All rights reserved.
Forward-Looking Statements
Vericel cautions you that all statements other than statements of historical fact included in this press release 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 factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Our actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Among the factors that could cause actual results to differ materially from those set forth in the forward-looking statements include, but are not limited to, uncertainties associated with our expectations regarding future revenue, growth in revenue, market penetration for MACI, MACI Arthro, Epicel, and NexoBrid, growth in profit, gross margins and operating margins, the ability to continue to scale our manufacturing operations to meet the demand for our cell therapy products, including the timely completion of a new headquarters and manufacturing facility in Burlington, Massachusetts, the ability to achieve or sustain profitability, contributions to adjusted EBITDA, the expected target surgeon audience, potential fluctuations in sales and volumes and our results of operations over the course of the year, timing and conduct of clinical trial and product development activities, timing and likelihood of the FDA’s potential approval of the use of MACI to treat cartilage defects in the ankle, the estimate of the commercial growth potential of our products and product candidates, competitive developments, changes in third-party coverage and reimbursement, surgeon adoption of MACI Arthro, physician and burn center adoption of NexoBrid, labor strikes, changes in surgeon and hospital treatment prioritizations caused by the temporary shortage of essential medical supplies, supply chain disruptions or other events or factors that might affect our ability to manufacture MACI or Epicel or affect MediWound’s ability to manufacture and supply sufficient quantities of NexoBrid to meet customer demand, including but not limited to, damage or disruption caused by natural disasters and the ongoing military conflicts in the Middle East region involving Israel, negative impacts on the global economy and capital markets resulting from the conflict in Ukraine and the Middle East conflicts, adverse developments affecting financial institutions, companies in the financial services industry or the financial services industry generally, global geopolitical tensions or record inflation and the potential future impacts on our business or the economy generally stemming from a public health emergency.
These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on February 29, 2024, Vericel’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 7, 2024, and in other filings with the SEC. These forward-looking statements reflect our views as of the date hereof and Vericel does not assume and specifically disclaims any obligation to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
Investor Contact:
Eric Burns
ir@vcel.com
+1 (734) 418-4411
Media Contact:
Julie Downs
media@vcel.com
| VERICEL CORPORATION | ||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (in thousands, except per share amounts - unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Product sales, net | $ | 57,905 | $ | 45,581 | $ | 161,848 | $ | 132,520 | ||||||||
| Total revenue | 57,905 | 45,581 | 161,848 | 132,520 | ||||||||||||
| Cost of product sales | 16,252 | 14,973 | 48,240 | 45,451 | ||||||||||||
| Gross profit | 41,653 | 30,608 | 113,608 | 87,069 | ||||||||||||
| Research and development | 6,093 | 5,676 | 19,874 | 16,141 | ||||||||||||
| Selling, general and administrative | 38,025 | 29,989 | 107,694 | 90,123 | ||||||||||||
| Total operating expenses | 44,118 | 35,665 | 127,568 | 106,264 | ||||||||||||
| Loss from operations | (2,465 | ) | (5,057 | ) | (13,960 | ) | (19,195 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 1,578 | 1,262 | 4,850 | 3,196 | ||||||||||||
| Interest expense | (154 | ) | (150 | ) | (460 | ) | (444 | ) | ||||||||
| Other income (expense) | 140 | (1 | ) | 125 | (18 | ) | ||||||||||
| Total other income | 1,564 | 1,111 | 4,515 | 2,734 | ||||||||||||
| Loss before income taxes | (901 | ) | (3,946 | ) | (9,445 | ) | (16,461 | ) | ||||||||
| Income tax benefit | — | (286 | ) | — | (286 | ) | ||||||||||
| Net loss | $ | (901 | ) | $ | (3,660 | ) | $ | (9,445 | ) | $ | (16,175 | ) | ||||
| Net loss per common share: | ||||||||||||||||
| Basic and diluted | $ | (0.02 | ) | $ | (0.08 | ) | $ | (0.19 | ) | $ | (0.34 | ) | ||||
| Weighted-average common shares outstanding: | ||||||||||||||||
| Basic and diluted | 49,085 | 47,649 | 48,639 | 47,537 | ||||||||||||
| VERICEL CORPORATION | ||||||||||||||||
| RECONCILIATION OF REPORTED NET LOSS (GAAP) | ||||||||||||||||
| TO ADJUSTED EBITDA (NON-GAAP MEASURE) | ||||||||||||||||
| (in thousands - unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net loss | $ | (901 | ) | $ | (3,660 | ) | $ | (9,445 | ) | $ | (16,175 | ) | ||||
| Stock-based compensation expense | 9,224 | 7,924 | 28,578 | 25,416 | ||||||||||||
| Depreciation and amortization | 1,326 | 1,154 | 4,027 | 3,483 | ||||||||||||
| Net interest income | (1,424 | ) | (1,112 | ) | (4,390 | ) | (2,752 | ) | ||||||||
| Income tax benefit | — | (286 | ) | — | (286 | ) | ||||||||||
| Pre-occupancy lease expense | 1,815 | 1,424 | 4,801 | 1,899 | ||||||||||||
| Adjusted EBITDA (Non-GAAP) | $ | 10,040 | $ | 5,444 | $ | 23,571 | $ | 11,585 | ||||||||
| VERICEL CORPORATION | ||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| (in thousands - unaudited) | ||||||
| September 30, | December 31, | |||||
| 2024 | 2023 | |||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 53,681 | $ | 69,088 | ||
| Restricted cash | 16,669 | 17,778 | ||||
| Short-term investments | 48,053 | 40,469 | ||||
| Accounts receivable (net of allowance for doubtful accounts of | 48,479 | 58,356 | ||||
| Inventory | 15,756 | 13,087 | ||||
| Other current assets | 7,882 | 6,853 | ||||
| Total current assets | 190,520 | 205,631 | ||||
| Property and equipment, net | 88,413 | 41,635 | ||||
| Intangible assets, net | 6,406 | 6,875 | ||||
| Right-of-use assets | 71,561 | 73,462 | ||||
| Long-term investments | 32,895 | 25,283 | ||||
| Other long-term assets | 610 | 771 | ||||
| Total assets | $ | 390,405 | $ | 353,657 | ||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 20,884 | $ | 22,347 | ||
| Accrued expenses | 14,343 | 17,215 | ||||
| Current portion of operating lease liabilities | 6,119 | 6,187 | ||||
| Total current liabilities | 41,346 | 45,749 | ||||
| Operating lease liabilities | 91,344 | 81,856 | ||||
| Other long-term liabilities | 243 | 100 | ||||
| Total liabilities | 132,933 | 127,705 | ||||
| Total shareholders’ equity | 257,472 | 225,952 | ||||
| Total liabilities and shareholders’ equity | $ | 390,405 | $ | 353,657 | ||
FAQ
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