VCEL 8-K
Vericel Corp (VCEL)
8-K
2024-01-09
For: 2024-01-09
View Original
Added on
April 11, 2026
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 9, 2024
(Exact name of registrant as specified in its charter)
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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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(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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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 42nd Annual J.P. Morgan Healthcare Conference, on January 9, 2024, 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, 2023. The Company’s corporate presentation
includes additional updates regarding its business.
Because the Company’s financial statements for the year ended December 31, 2023, 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, 2023, 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 9, 2024, press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).
| Item 7.01. |
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 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California, which is
being held on Wednesday, January 10, 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 2023, its estimated cash and investments balance as of
December 31, 2023, 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.
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 9, 2024, titled “Vericel Announces Preliminary Full-Year and Fourth Quarter 2023 Financial Results”
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| 99.2 | Vericel Corporation Presentation, dated January 9, 2024 | |
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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 9, 2024, titled “Vericel Announces Preliminary Full-Year and Fourth Quarter 2023 Financial Results”
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| 99.2 | Vericel Corporation Presentation, dated January 9, 2024 | |
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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 9, 2024
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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: Senior Vice President, General Counsel and Secretary
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Exhibit 99.1
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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 Full-Year and Fourth Quarter 2023 Financial Results
Full-Year Total Revenue Expected to be Approximately $197.5 Million, Representing 20% Growth, with Fourth Quarter Revenue Growth of 23%
to $65 Million
MACI Full-Year Revenue Expected to be Approximately $164.8 Million, Representing 25% Growth, with Fourth Quarter Revenue Growth of 22% to
$56.7M
Fourth Quarter Burn Care Revenue Growth of Approximately 31%
CAMBRIDGE, Mass., January 9, 2024 (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, 2023.
Preliminary, Unaudited Full-Year 2023 Financial Results
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Total net revenue expected to be approximately $197.5 million, representing 20% growth
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MACI® net revenue expected to be approximately $164.8 million, representing 25% growth
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Burn Care net revenue expected to be approximately $32.7 million, consisting of approximately $31.6 million of Epicel® revenue and $1.1 million of NexoBrid® revenue
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Gross margin expected to be in the high-60% range
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Adjusted EBITDA margin expected to be in the mid-teens percentage range, with full-year adjusted EBITDA growth expected to be approximately 30%
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As of December 31, 2023, the Company had approximately $152 million in cash, restricted cash and investments and no debt
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Preliminary, Unaudited Fourth Quarter Financial Results and Commercial Highlights
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Total net revenue expected to be approximately $65.0 million, representing 23% growth
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MACI net revenue expected to be approximately $56.7 million, representing 22% growth, marking the sixth straight quarter of 20%+ MACI growth
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Burn Care net revenue expected to be approximately $8.3 million, representing 31% growth, consisting of approximately $7.8 million of Epicel revenue and $0.5 million of NexoBrid revenue
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Positive adjusted EBITDA and Operating Cash Flow expected for the 14th straight quarter
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Gross margin expected to be greater than 70%
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Adjusted EBITDA margin expected to be approximately 30%
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Highest number of MACI implants, implanting surgeons, surgeons taking biopsies and MACI biopsies in a quarter since launch
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Highest number of Epicel biopsies in a quarter since 2021
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NexoBrid commercial launch in the U.S., with over 50 burn centers submitting packages to Pharmacy and Therapeutics (P&T) committees and over 25 burn centers with P&T committee
approvals
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“The Company had a very strong close to the year with outstanding fourth quarter financial results driven by high revenue growth in both of our franchises and
strong business fundamentals across our portfolio,” said Nick Colangelo, President and CEO of Vericel. “We enter 2024 with a great deal of momentum and expect another year of high revenue growth and increasing profitability driven by continued
strong execution with our core products, a full year of NexoBrid on the U.S. market and the anticipated launch of arthroscopic MACI later this year.”
Vericel is scheduled to present at the 42nd Annual J.P. Morgan Healthcare Conference at 10:30 a.m. ET (7:30 a.m. PT) on Wednesday, January 10, 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 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 the removal of eschar in adults 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. © 2024 Vericel Corporation. All rights reserved.
Preliminary and Unaudited Nature of Reported Results
Our revenue expectations for the fourth quarter and full-year ended 2023,
as well as our estimates concerning adjusted EBITDA, operating cash flows, 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, 2023. Accordingly, you
should not place undue reliance on this preliminary estimate.
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GAAP v. Non‑GAAP Measures
Vericel has provided in this release certain financial information that has not been prepared in accordance with generally accepted
accounting principles in the United States, or GAAP. Vericel’s management believes that the non-GAAP adjusted EBITDA described in the 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
2023, adjusted EBITDA, operating cash flow, and estimates of our cash, restricted cash and investments as of December 31, 2023. Vericel’s revenue expectations for the fourth quarter and full-year ended 2023, as well as its estimates concerning
adjusted EBITDA, operating cash flow, 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, 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 arthroscopic delivery of MACI to the knee or 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, physician and burn center adoption of NexoBrid, supply chain disruptions or other events or factors affecting MediWound’s ability to manufacture and
supply sufficient quantities of NexoBrid to meet customer demand, including but not limited to the ongoing Israel-Hamas war, negative impacts on the global economy and capital markets resulting from the conflict in Ukraine and the Israel-Hamas
war, adverse developments affecting financial institutions, companies in the financial services industry or the financial services industry generally, global geopolitical tensions or record inflation and potential future impacts on our business
or the economy generally stemming from a resurgence of COVID-19 or another similar public health emergency.
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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, 2022, filed with
the Securities and Exchange Commission (SEC) on February 23, 2023, Vericel’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the SEC on November 8, 2023, 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
+1 (734) 418-4411
Media Contact:
Julie Downs
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Exhibit 99.2
