8-K

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

Vericel Corporation

(Exact name of registrant as specified in its charter)

Michigan	001-35280	94-3096597
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

64 Sidney Street Cambridge, MA	02139
(Address of principal executive offices)	(Zip Code)

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):

☐
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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, no par value	VCEL	NASDAQ

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. ☐

Item 2.02. Results of Operations and Financial Condition.

In connection with its participation in the 42^nd 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.

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 42^nd 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.

Exhibit No.	Description
99.1	Press Release, dated January 9, 2024, titled “Vericel Announces Preliminary Full-Year and Fourth Quarter 2023 Financial Results”
99.2	Vericel Corporation Presentation, dated January 9, 2024
104 *	Cover Page Interactive Data File (embedded within the Inline XBRL)

* Furnished herewith

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press Release, dated January 9, 2024, titled “Vericel Announces Preliminary Full-Year and Fourth Quarter 2023 Financial Results”
99.2	Vericel Corporation Presentation, dated January 9, 2024
104 *	Cover Page Interactive Data File (embedded within the Inline XBRL)

* 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.

	Vericel Corporation
Date: January 9, 2024	By:	/s/ Sean C. Flynn
		Name: Sean C. Flynn
		Title: Senior Vice President, General Counsel and Secretary

EX-99.1

Exhibit 99.1

Vericel Corporation 64 Sidney Street Cambridge, MA  02139 T 617 588-5555  F 617 588-5554 www.vcel.com

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

• Total net revenue expected to be approximately $197.5 million, representing 20% growth

• MACI^® net revenue expected to be approximately $164.8 million, representing 25% growth

• 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

• Gross margin expected to be in the high-60% range

• Adjusted EBITDA margin expected to be in the mid-teens percentage range, with full-year adjusted EBITDA growth expected to be approximately 30%

• As of December 31, 2023, the Company had approximately $152 million in cash, restricted cash and investments and no debt

Preliminary, Unaudited Fourth Quarter Financial Results and Commercial Highlights

• Total net revenue expected to be approximately $65.0 million, representing 23% growth

• MACI net revenue expected to be approximately $56.7 million, representing 22% growth, marking the sixth straight quarter of 20%+ MACI growth

• 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

• Positive adjusted EBITDA and Operating Cash Flow expected for the 14^th straight quarter

• Gross margin expected to be greater than 70%

• Adjusted EBITDA margin expected to be approximately 30%

• Highest number of MACI implants, implanting surgeons, surgeons taking biopsies and MACI biopsies in a quarter since launch

• Highest number of Epicel biopsies in a quarter since 2021

• 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

“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 42^nd 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

ir@vcel.com

+1 (734) 418-4411

Media Contact:

Julie Downs

media@vcel.com

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EX-99.2

Exhibit 99.2

 Advanced Therapies for the Sports Medicine & Severe Burn Care Markets  42ND ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE  JANUARY 10, 2024 

 Forward-Looking Statements and Legal Disclosure  2  Forward-Looking Statements  Vericel cautions you that all statements other than statements of historical fact included in this presentation 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 presentation. 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 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.  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.  Discussion of Indications Currently Under Development Additionally, portions of this presentation discuss the potential clinical advantages of the arthroscopic delivery of MACI to treat cartilage defects in the knee joint and the use of MACI in the ankle joint, as well as the potential effect the approval of those additional indications could have on MACI’s total addressable market. The reader is reminded that the implantation of MACI in the knee is currently approved to be performed via an arthrotomy. The arthroscopic delivery of MACI to the knee joint and the use of MACI in the ankle joint are currently under development and such uses have not been approved in the U.S. 

 Vericel is a Leader in Advanced Therapies in Sports Medicine and Burn Care, Combining Innovations in Biology with Medical Technologies  Our Vision  Every patient benefits from therapies as unique as they are  Our Mission  We provide precision therapies that repair injuries and restore lives  SPORTS MEDICINE SEVERE BURNS  Portfolio of Innovative Cell Therapies and Specialty Biologics with Significant Barriers to Entry  3 

 ❶  Strong Financial Profile  ❷  High-Growth Sports Medicine Franchise  ❸  Advancing Pipeline  ❹  Second High- Growth Franchise in Burn Care  Market leader in knee cartilage repair  ~25% growth in 2023  Continued strong growth in MACI surgeons and biopsies  High revenue growth profile  Sustained positive adjusted EBITDA & Operating Cash Flow  ~$152 Million in Cash and  Investments  NexoBrid sBLA for pediatric indication accepted for review  MACI Ankle program advancing  MACI Arthro submission accepted for review; projected launch in Q3 2024  4  Vericel is Well-Positioned to Deliver Sustained Long-Term Growth  Launched in the U.S. in Q4 2023; high surgeon interest to date  Potentially life-saving product with large market opportunity  Full-year 2023 revenue, adjusted EBITDA and operating cash flow, and cash and investments balances are based on preliminary unaudited 2023 financial results and are subject to change. 

  MACI Revenue Growth of ~25% to ~$164.8M   Gross Margin Expansion to High-60% Range   Adjusted EBITDA Margin in Mid-Teens % Range, representing ~30% Full-Year Growth   NexoBrid Launched in Fourth Quarter of 2023   MACI Arthro Human Factors Study Completed and Submission Accepted for Review by FDA   Total Company Revenue Growth of ~20% to ~$197.5M  Total Company Revenue Growth of 20%+  Second High-Growth Franchise for Vericel Burn Care  with First Full Year of NexoBrid Revenue  Launch of MACI Arthro in Q3 2024, Enabling Greater  Penetration in Largest Segment of MACI’s $3B TAM  Inflection Point for Profitability with Further Gross  Margin and Adjusted EBITDA Margin Expansion  On Track to Achieve GAAP Profitability in 2024  Outstanding Results Across the Company in 2023  5  Continued  Momentum  2023 Achievements  2024 Value Drivers  With Expectations for Further Revenue and Profit Growth in 2024  Full-year 2023 revenue, gross margin and Adjusted EBITDA are based on preliminary unaudited 2023 financial  results and are subject to change. 2024 estimates are based on internal financial projections. 

 Large Underpenetrated Markets with Total Addressable Market Opportunity Expanding to Over $4.5 Billion in the Years Ahead  6  $3 Billion  + $300 Million  + $1Billion  $4 Billion  $600 Million  Core TAM  Expanded TAM  NexoBrid launched in Q4 2023  MACI Arthro targeting largest segment of current TAM and expected to launch in Q3 2024  MACI Ankle trial anticipated to initiate in 2025  $3+ Billion  TAM  $4.5+ Billion  TAM  $300 Million 

 Core Portfolio Plus Multiple New Product Launches Expected to Drive Further Strong Revenue Growth in 2024 and Beyond  7  Durable Growth Platform  Significantly underpenetrated markets  Limited competition with strong barriers to entry  Strong reimbursement profiles  +  With Additional Growth Drivers in 2024+  First full year of NexoBrid revenue in 2024  MACI Arthro launch in Q3 2024, with first full year of  revenue in 2025  2024 2025  20%+  20%+  2017  2018 2019 2020 2021  2022  2023  Top-Tier Revenue Growth  Sports Med Burn Care  ~$197.5M  +20%  + +  Full-year 2023 revenue is based on preliminary unaudited 2023 financial results and is subject to change; 2024 and 2025 estimates based on internal financial projections. 

 High Revenue Growth  Increasing Gross Margins  Increased Profitability  Expanding EBITDA Margins  Driving High Revenue Growth While Progressing Toward Top-Tier Profitability Profile  8  Adjusted EBITDA Margin %  Gross Margin %  52%  High  60s %  ~70%  70%+  2017  2023  2024  2025+  Mid- Teens %  ~20%  ~30%  2017  -19%  2023  2024  2025+  20% Top Line Growth in 2023  Expect Continued 20%+ Growth in 2024+  ~30% Adjusted EBITDA Growth in 2023  Expect Strong Adjusted EBITDA Growth and GAAP Profitability in 2024+  Full-year 2023 revenue, gross margin and Adjusted EBITDA are based on preliminary unaudited 2023 financial results and are subject to change. 2024 and 2025+ estimates are based on internal financial projections. 

 9  Knee Cartilage Injuries Represent a Significant Unmet Medical Need  Cartilage defects are found in ~60% of knee arthroscopies1  Damage is caused by acute or repetitive trauma or degenerative conditions  Cartilage has limited capacity for intrinsic healing and repair  Untreated cartilage defects may lead to debilitating joint pain, dysfunction, and osteoarthritis  Defects can expand and new high-grade lesions can form over time  > > > >  > > > >  TIME  1 Widuchowski W, et al. Articular cartilage defects: study of 25,124 knee arthroscopies. Knee. Jun 2007.  2 Data collected from a 2019 Harris Poll survey of 1,002 U.S. adults with knee pain 3 or more days a week that had lasted 2 months or more.  Harris Poll found that 77% of knee pain sufferers can no longer participate in at least one activity they previously enjoyed because of knee pain2 

 Large Addressable Knee Cartilage Repair Market for MACI  1 Health Advances LLC MACI market assessment report (2018), Vericel data, LexisNexis, Medtech Insight, NY SASD, SmartTRAK, LSI, PSPS, McCormick, Frank et al. Arthroscopy, (2014) 30(2): 222-6, Montgomery, et al. Knee Surg Sports Traumatol Arthrosc (2014) 22: 2070.  2 Health Advances LLC MACI market assessment report (2018).  3 Assumes MACI ASP of ~$50,000+.  4 2023 MACI revenue based on preliminary unaudited 2023 financial results and are subject to change.  10  Estimated Annual Addressable  Patient Population (U.S.)  ~315,0002  Patients  Consistent With Label  ~125,0002  Patients MD’s Consider  Clinically Appropriate For MACI  ~750,0001  Cartilage Repair Procedures  ~60,0002 Patients With Larger Lesions  $3 Billion Addressable Market in the U.S.3  $68  $44  $92  $95  $112  $132  Annual Cartilage Repair Revenue  ~$164.84  $Millions  2017 2018 2019 2020 2021 2022 2023  Mid teens % biopsy penetration  Mid single-digit % implant penetration 

 MACI is the Leading Restorative Cartilage Repair Product on the Market  11  BIOPSY TAKEN  CHONDROCYTES EXTRACTED, EXPANDED,  & LOADED  MACI DELIVERED  DEFECT DEBRIDED  TEMPLATE CREATED  MACI IMPLANTED 

 MACI Product Attributes Driving Strong Growth Since Launch  12  Broad Label with Strong Clinical Data  Shorter Rehab Protocols  Strong Reimbursement Profile  Simpler, Less Invasive Procedure 

 Surgeon Adoption Continues to be a Key MACI Growth Driver and Target Surgeons Will Increase With MACI Arthro Launch in 2024  13  2017-2019  Initial Launch  2020-2024  Expanded Open-Only Targets  2024+  Open and Arthro  # Surgeons  Taking Biopsies  3,000  Targets  5,000  Targets  7,000  Targets  ~50%  penetration  ~50%  penetration  Expect 50%+  penetration  Double-digit biopsy surgeon CAGR since launch  Arthroscopic option adds  ~2,000  additional surgeon targets  MACI Arthro  expected to be a key growth driver in 2024 and beyond 

 Building a Robust and Innovative Pipeline Through Lifecycle Management and Business Development  14  Key Highlights  MACI Arthroscopic Delivery  MACI Arthro submission accepted for review; projected launch in Q3 2024  MACI Ankle Indication  Trial anticipated to initiate in 2025  NexoBrid  Launched in Q4 2023  sBLA for pediatric indication accepted for review 

 MACI Arthro  15  Arthroscopic MACI Delivery Provides a Significant Growth Opportunity  1Based on Health Advances, LLC MACI market assessment report (2018).  High Surgeon Interest in MACI Arthro  Potential for Increased MACI Volume  ~90%  % of target surgeons expressed Interest in arthro MACI option1  ~90%  % of current MACI users would expect to Increase MACI volume1  Upon Launch MACI Arthro Will be the Only Restorative Cartilage  Repair Product That Can be Administered Arthroscopically  Click here to view an animation of the MACI arthroscopic delivery surgical technique 

 Arthroscopic MACI is Targeting 2-4cm2 Femoral Condyle Defects, Which Represents the Largest Portion of the MACI Addressable Market  16  MACI TAM Segmented  by Defect Type  1 Health Advances LLC MACI market assessment report (2018), Vericel data, LexisNexis, Medtech Insight, NY SASD, SmartTRAK, LSI, PSPS, McCormick, Frank et al. Arthroscopy, (2014) 30(2): 222-6, Montgomery, et al. Knee Surg Sports Traumatol Arthrosc (2014) 22: 2070.  2 Health Advances LLC MACI market assessment report (2018).  3 Assumes MACI ASP of ~$50,000+.  4 Includes defects on tibia, trochlea and other condyle defects.  Estimated Annual Addressable Patient Population (U.S.)  ~315,0002  Patients Consistent With Label  ~125,0002  Patients MD’s Consider  Clinically Appropriate For MACI  ~750,0001  Cartilage Repair Procedures  ~60,0002 Patients With Larger Lesions  2-4cm Condyle  Other  Patella  2  10%+ overall penetration currently  Continues to be area of growth  Similar penetration as in patella would  ~double total MACI revenue  4  2 

 17  Significant Ankle Cartilage Repair Opportunity  OATs  MFX+  Minced allograft  MFX alone  OCA  Minced autograft  Other  MACI Ankle Annual TAM Estimate (U.S.)  ~66,0002  Patients MD’s Consider Clinically Appropriate For MACI  ~165,0001   Ankle Resurfacing Procedures  Current Treatment Breakdown2  MACI for the treatment of cartilage defects in the ankle represents a $1 billion3 market  opportunity  ~~1188,0,0000022  LLaarrggeerrLLeessioionnss  1 SmartTrak Cartilage Repair Procedures; resurfacing includes microfracture, OATs, OCA, etc. and does not include chondroplasty/debridement only.  2 Cello Health MACI Ankle quantitative market research survey (2021).  3 Assumes MACI ASP of $50,000+. 

 Potential MACI Ankle Indication Would Increase MACI Total Addressable Market to $4 Billion  18  1 Health Advances LLC MACI market assessment report (2018), Vericel data, LexisNexis, Medtech Insight, NY SASD, SmartTRAK, LSI, PSPS, McCormick, Frank et al. Arthroscopy, (2014) 30(2): 222-6, Montgomery, et al. Knee Surg Sports Traumatol Arthrosc (2014) 22: 2070. 2 Health Advances LLC MACI market assessment report (2018) 3 Assumes MACI ASP of $50,000+. 4 SmartTrak Cartilage Repair Procedures; resurfacing includes microfracture, OATs, OCA, etc. and does not include chondroplasty/debridement only. 5 Cello Health MACI Ankle quantitative market research survey (2021).  $4 Billion  Addressable Market in the U.S.  Current MACI Knee Annual U.S. TAM (est.)  ~315,0002  Patients  Consistent With Label  ~125,0002  Patients MD’s Consider  Clinically Appropriate For MACI  ~750,0001  Cartilage Repair Procedures  ~60,0002 Patients With Larger Lesions  MACI Ankle Annual U.S. TAM (est.)  ~66,0002  Patients MD’s Consider Clinically Appropriate For MACI  ~165,0001   Ankle Resurfacing Procedures  ~1~8~1,10880,,0000500022  LarLLgaaerrgrgeLererLsLieoesnsioisonnss  $  1  Billion  Addressable Market in the U.S.  $3  Billion  Addressable Market in the U.S.3 

 Patient admittance to hospital  Patient stabilization & wound assessment  Superficial/Superficial Partial Thickness  Spontaneous healing  Deep Partial Thickness  Surgical or enzymatic debridement  Post debridement evaluation  Spontaneous healing  Skin grafting (if necessary)  Full Thickness  Surgical or enzymatic debridement  Skin grafting (permanent skin coverage)  19  Burn Injury Size and Depth Determine Treatment Pathway  Full thickness burn injuries of any size & partial thickness burn injuries >10% total body surface area (TBSA) are most often transferred to specialized burn centers  Full thickness & deep partial-thickness burns require  eschar removal and grafting to achieve wound closure  EMERGENCY ADMIT  INITIAL ASSESSMENT  ESCHAR REMOVAL  EVALUATION  TREATMENT/HEALING  T R E A T M E N T  P A T H W A Y  Epidermis  Dermis  Subcutaneous fat  Muscle  Bone  Superficial (1st Degree)  Superficial Partial-Thickness (2nd Degree)  Deep Partial-Thickness (2nd Degree)  Full Thickness (3rd Degree)  Fourth Degree 

 Burn Care Franchise Addressable Market Opportunity  20  $300 Million Addressable Market in the U.S.4  Estimated U.S. Burn Patients1  500,000  Annual Burns (U.S.)  1,500  Epicel-Indicated (>30% TBSA)  Patients  600 Surviving  >40% TBSA Patients  $300 Million Addressable Market in the U.S.2,3  40,000  Hospitalized Patients  1 2017 National Burn Repository Report Version 13.  2 ~90% of hospitalized patients with thermal burns; ~90% of eligible patients require eschar removal (management estimate).  3 Assumes NexoBrid average price of ~$9,000 per patient.  4 Assumes 600 patients x 120 grafts per patient x ~$4,000+ per graft.  NexoBrid commercialization significantly expands the total addressable market and establishes second high growth franchise for Vericel  $600 Million Addressable Market in the U.S. 

 NexoBrid  Indications and Usage: Contains proteolytic enzymes and is indicated for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns  NexoBrid can be applied to up to 20% body surface area in two applications  Significant Advancement in Burn Treatment Paradigm  Concentrated mixture of proteolytic enzymes derived from the stem of the pineapple plant (Ananas comosus)  Non-surgical topical agent that may be applied at the patient’s bedside  Selectively degrades eschar in four hours while preserving viable tissue  1 NexoBrid Label. Cambridge, MA. Vericel Corporation; 2022.  2 Krieger Y, Bogdanov-Berezovsky A, Gurfinkel R, et al. Efficacy of enzymatic debridement of deeply burned hands. Burns. 2012;38:108-112.  3 Palao R, Aguilera-Saez J, Collado JM, et al. Use of a selective enzymatic debridement agent (NexoBrid) for wound management: Learning 21  curve. World J Dermatol. 2017;6(2):32-41. 

 NexoBrid Treatment Application  22  Clean Wound  Antibacterial Pre-Soak  NexoBrid Application  Film Dressing (4 Hours)  Remove Eschar  Images are for illustration and demonstration purposes only; patients will experience individualized results from the use of NexoBrid to treat severe thermal burns. 

 NexoBrid Launch Progress  23  NexoBrid launched in the  U.S. in Q4 2023  Key Performance Indicators  50+ Burn Centers have submitted packages to their P&T Committees  25+ Burn Centers have P&T Committee approval  ~20 Burn Centers have  placed initial orders  Robust Clinical Efficacy  Strong Interest in NexoBrid by Treating Physicians and Burn Centers  Application Demonstrations  Multi-Disciplinary Education & Clinical Application Training  NEXOBRID IS NOW COMMERCIALLY AVAILABLE IN THE U.S 

 Epicel  24  Comparison of Epicel Patient Database to National Burn Repository1 Data Demonstrates Lower Mortality Rate  Twenty-five Years’ Experience and Beyond with Cultured Epidermal Autografts (CEA) for Coverage of Large Burn Wounds in Adult and Pediatric Patients, 1989-2015; Hickerson, Journal of Burn Care & Research, iry061, https://doi.org/10.1093/jbcr/iry061.  1 American Burn Association, National Burn Repository 2016, Version 12.  Only FDA-approved permanent skin replacement for adult and pediatric patients with full-  thickness burns ≥ 30% of total  body surface area  Important treatment option for severe burn patients where little skin is available for autografts 

 Vericel Remains Focused on Potential Strategic Transactions to Maximize Long-Term Value  Business development activities focused on opportunities having a strategic fit with current franchises or advanced cell therapy platform  25  Sports Medicine  Franchise  Severe Burn Care  Franchise  A D VA N C E D C E L L T H E R A P Y D E V E L O P M E N T &  M A N U FA C T U R I N G P L AT F O R M  New Advanced Cell  Therapy Vertical(s) 

 Growth Strategy Leverages Near-Term & Long-Term Opportunities  Strong Financial  Profile  High revenue growth profile  Sustained positive adjusted EBITDA and Operating Cash Flow  ~$152 Million in cash and investments  High-Growth Sports  Medicine Franchise  Market leader in knee cartilage repair  20%+ total revenue  CAGR since 2017  Focused on maximizing key growth drivers  26  Advancing  Pipeline  MACI Arthro submission accepted for review  MACI Ankle program  advancing  NexoBrid sBLA for pediatric indication accepted for review  Second High-Growth  Franchise in Burn Care  NexoBrid launched in Q4 2023  High surgeon interest to  date 

XML

Document and Entity Information	Jan. 09, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 09, 2024
Entity File Number	001-35280
Entity Registrant Name	Vericel Corporation
Entity Central Index Key	0000887359
Entity Incorporation, State or Country Code	MI
Entity Tax Identification Number	94-3096597
Entity Address, Address Line One	64 Sidney Street
Entity Address, City or Town	Cambridge
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02139
City Area Code	617
Local Phone Number	588-5555
Title of 12(b) Security	Common Stock, no par value
Trading Symbol	VCEL
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false