UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): January 14, 2025
Vericel Corporation
(Exact name of registrant as specified in its charter)
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Michigan
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001-35280
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94-3096597
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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64 Sidney Street
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Cambridge, MA
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02139
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code: (617) 588-5555
Not Applicable
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, no par value
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VCEL
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NASDAQ
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Indicate by a check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§240.12b-2 of this
chapter). Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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Results of Operations and Financial Condition.
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In connection with its participation in the 43rd Annual J.P. Morgan Healthcare Conference, on January 14, 2025, Vericel Corporation (the
“Company”) issued a press release and updated its corporate presentation, both of which include estimates of operating and financial results as of and for the year ended December 31, 2024. The Company’s corporate presentation includes additional
updates regarding its business.
Because the Company’s financial statements for the year ended December 31, 2024, have not been finalized or audited, these preliminary statements
regarding the Company’s operating and financial results as of and for the year ended December 31, 2024, are subject to change and the Company’s actual results as of the end of this period may differ materially from this preliminary estimate.
Accordingly, stockholders should not place undue reliance on this preliminary estimate. A copy of the Company’s January 14, 2025, press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).
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Regulation FD Disclosure.
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The information set forth in Item 2.02 of this Report is incorporated into this Item 7.01 by reference.
The Company will participate in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, California, which is being held on
Wednesday, January 15, 2024, at 7:30 a.m. Pacific Time, and has updated the corporate presentation that the Company intends to use at the conference. The Company may use this updated corporate presentation in meetings with investors from time to
time as well. The Company’s updated corporate presentation includes disclosure regarding the Company’s estimated, preliminary and unaudited full-year revenue for fiscal year 2024, preliminary adjusted EBITDA and adjusted EBITDA margin for 2024,
preliminary and unaudited 2024 gross margin percentage, preliminary and unaudited 2024 net income, its estimated cash, restricted cash and investments balance as of December 31, 2024, and additional financial and business updates.
A copy of the Company’s updated corporate presentation is attached hereto as Exhibit 99.2 and is hereby incorporated by reference.
The preliminary financial data included in this Current Report on Form 8-K has been prepared by, and is the responsibility of, the Company’s management.
PricewaterhouseCoopers LLP has not audited, reviewed, examined, compiled, nor applied agreed-upon procedures with respect to the preliminary financial data. Accordingly, PricewaterhouseCoopers LLP does not express an opinion or any other form of
assurance with respect thereto.
In accordance with General Instructions B.2 and B.6 of Form 8-K, the information included in Item 2.02 and Item 7.01 of this Report shall not be deemed
“filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the
Company under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01. |
Financial Statements and Exhibits.
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Exhibit No.
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Description
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99.1
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Press Release, dated January 14, 2025, titled “Vericel Announces Preliminary 2024 Financial Results, 2025 Financial Guidance and Increased Mid-Term Profitability Targets”
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99.2
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Vericel Corporation Presentation, dated January 14, 2025
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104 *
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Cover Page Interactive Data File (embedded within the Inline XBRL)
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* Furnished herewith
EXHIBIT INDEX
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Exhibit No.
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Description
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Press Release, dated January 14, 2025, titled “Vericel Announces Preliminary 2024 Financial Results, 2025 Financial Guidance and Increased Mid-Term Profitability
Targets”
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Vericel Corporation Presentation, dated January 14, 2025
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104 *
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Cover Page Interactive Data File (embedded within the Inline XBRL)
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* Furnished herewith.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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Vericel Corporation
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Date: January 14, 2025
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By:
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/s/ Sean C. Flynn
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Name: Sean C. Flynn
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Title: Chief Legal Officer
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Vericel Corporation
64 Sidney Street
Cambridge, MA 02139
T 617
588-5555 F 617 588-5554
www.vcel.com
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Vericel Announces Preliminary 2024 Financial Results, 2025 Financial Guidance and Increased Mid-Term Profitability Targets
Full-Year 2024 Total Revenue Growth of 20% and Adjusted EBITDA Growth of Approximately 55%
MACI Full-Year 2024 Revenue Growth of 20%, with Fourth Quarter Revenue of $68.2 to $68.7 Million
Highest Quarterly MACI Implants, Surgeons, and Biopsies Since Launch and Strong Early MACI Arthro Launch Indicators
Record Fourth Quarter Gross Margin of Approximately 77% and Adjusted EBITDA Margin of 39%
2025 Total Revenue Guidance of 20% to 23% Growth
Mid-Term Profitability Targets Increased to Gross Margin in the High-70% Range and Adjusted EBITDA Margin in the High-30% Range
CAMBRIDGE, Mass., January 14, 2025 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care
markets, today announced preliminary, unaudited financial results for the fourth quarter and year ended December 31, 2024, full-year 2025 financial guidance and updated mid-term profitability targets.
Preliminary, Unaudited Full-Year 2024 Financial Results
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Total net revenue expected to be approximately $237 to $237.5 million, representing 20% growth
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MACI® net revenue expected to be approximately $197.2 to $197.7 million, representing 20% growth
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Burn Care net revenue expected to be approximately $40 million, representing 22% growth, consisting of approximately $36.6 million of Epicel® revenue and $3.3 million of NexoBrid®
revenue
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Gross margin expected to be approximately 72.5%
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Achieved Full-Year GAAP Net Income profitability
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Non-GAAP adjusted EBITDA margin expected to be approximately 22%
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As of December 31, 2024, the Company had approximately $167 million in cash, restricted cash and investments, and no debt, an increase of approximately $16 million for the quarter
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Preliminary, Unaudited Fourth Quarter Financial Results
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Total net revenue expected to be approximately $75.2 million to $75.7 million
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MACI net revenue expected to be approximately $68.2 to $68.7 million, representing 20% to 21% growth versus the prior year and approximately 53% growth versus the prior quarter
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Burn Care net revenue expected to be approximately $7 million, consisting of approximately $6 million of Epicel revenue and $1 million of NexoBrid revenue
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Gross margin expected to be approximately 77%
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GAAP Net Income expected to be approximately $17.5 to $18.5 million
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Non-GAAP adjusted EBITDA margin expected to be approximately 39%
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Key Business Highlights and Updates
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Highest number of MACI implants, implanting surgeons, surgeons taking biopsies and MACI biopsies in any quarter since launch in the fourth quarter
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More than 150 MACI Arthro trained surgeons through year-end
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NexoBrid hospital orders in the fourth quarter increased approximately 40% versus the prior quarter
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Completed construction of new corporate headquarters and manufacturing facility and remain on track to initiate commercial manufacturing in the new facility in 2026
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2025 Financial Guidance
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Total net revenue growth for 2025 expected to be 20% to 23%
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Gross margin expected to be 73% to 74%
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Adjusted EBITDA margin expected to be 25% to 26%
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Mid-Term Profitability Targets
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Gross margin is expected to increase to the high-70% range by 2029
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Adjusted EBITDA margin expected to increase to the high-30% range by 2029
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“The Company executed extremely well in 2024, delivering high revenue growth across both franchises and very strong margin expansion and profitability,” said Nick
Colangelo, President and CEO of Vericel. “We are entering 2025 with a great deal of momentum and expect another year of high revenue growth, increasing utilization of MACI Arthro and significant growth in profitability and cash generation as we
continue to progress toward our mid-term financial targets.”
Vericel is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference at 10:30 a.m. ET (7:30 a.m. PT) on Wednesday, January 15, 2025. 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 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 30% of total body surface area. Vericel also holds an exclusive license for North American rights to NexoBrid
(anacaulase-bcdb), a biological orphan product containing proteolytic enzymes, which is indicated for eschar removal in adults and pediatric patients with deep partial-thickness and/or full-thickness burns. For more information, please visit www.vcel.com.
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. © 2025 Vericel Corporation. All rights reserved.
Preliminary and Unaudited Nature of Reported Results
Our revenue expectations for the fourth quarter and full-year ended 2024, as well as
our estimates concerning gross margin, net income, adjusted EBITDA, cash, restricted cash and investments are preliminary, unaudited and are subject to change based on the completion of ongoing internal control, review, and audit procedures. As a
result, these amounts may differ materially from the amounts that will be reflected in the Company’s consolidated financial statements for the year ended December 31, 2024. Accordingly, you should not place
undue reliance on this preliminary estimate.
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.
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, the inherent uncertainties associated with our expectations concerning expected revenue results for the fourth quarter and full-year ended 2024, gross margin, net income, adjusted EBITDA, and estimates of our cash, restricted cash and
investments as of December 31, 2024. Vericel’s revenue expectations for the fourth quarter and full-year ended 2024, as well as its estimates concerning gross margin, net income, adjusted EBITDA, and cash, restricted cash and investments are
preliminary, unaudited and are subject to change during ongoing internal control, review and audit procedures. Additional 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 qualification of a new manufacturing facility in Burlington, Massachusetts, the ability to 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,
changes in trade policies and regulations, including the potential for increases or changes in duties, current and potentially new tariffs or quotas, lingering effects of adverse developments affecting financial institutions, companies in the
financial services industry or the financial services industry generally, possible changes in governmental monetary and fiscal policies, including, but not limited to, Federal Reserve policies in connection with continued inflationary pressures and
the impact of the recent elections in the United States, global geopolitical tensions and 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 press release except as required by law.
Investor Contact:
Eric Burns
ir@vcel.com
+1 (734) 418-4411
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