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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 10, 2023

 

Vericel Corporation

(Exact name of registrant as specified in its charter)

  

Michigan     001-35280   94-3096597

(State or other

jurisdiction of

   

(Commission File

Number)

 

(I.R.S. Employer

Identification No.)

incorporation)          

 

  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)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ 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. o

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

In connection with its participation in the 41st Annual J.P. Morgan Healthcare conference, on January 10, 2023, 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, 2022, as well as other updates regarding its business.

 

Because the Company’s financial statements for the year ended December 31, 2022, 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, 2022, 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 10, 2023, 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 41st Annual J.P. Morgan Healthcare Conference in San Francisco, California, which is being held on Wednesday, January 11, 2022, 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 2022, its estimated cash and investments balance as of December 31, 2022, 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 10, 2023, titled “Vericel Announces Preliminary Fourth-Quarter and Full-Year 2022 Financial Results and Accelerated Launch Timeline for MACI Arthroscopic Program”
99.2   Vericel Corporation Presentation, dated January 10, 2023
104 *   Cover Page Interactive Data File (embedded within the Inline XBRL)

 

* Furnished herewith

 

  

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
99.1       Press Release, dated January 10, 2023, titled “Vericel Announces Preliminary Fourth-Quarter and Full-Year 2022 Financial Results and Accelerated Launch Timeline for MACI Arthroscopic Program”
99.2   Vericel Corporation Presentation, dated January 10, 2023
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 10, 2023 By: /s/ Sean C. Flynn
    Name: Sean C. Flynn
    Title: Senior Vice President, General Counsel and Secretary

 

  

 

 

Exhibit 99.1

 

   

 

Vericel Announces Preliminary Fourth-Quarter and Full-Year 2022 Financial Results and Accelerated Launch Timeline for MACI Arthroscopic Program

 

Full-Year Total Revenue Expected to be Approximately $164 to $165 Million

 

MACI Full-Year Revenue Expected to be at the High End of Guidance Range, with Fourth Quarter Revenue Growth of Approximately 24%

 

MACI Arthroscopic Commercial Launch Now Planned for 2024

 

CAMBRIDGE, Mass., January 10, 2023 (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, 2022 and an accelerated launch timeline for MACI® arthroscopic delivery, which is now anticipated to be launched in 2024.

 

Preliminary, Unaudited Fourth-Quarter and Full-Year 2022 Financial Results

 

·Total net revenue for full-year 2022 expected to be approximately $164 to $165 million
·MACI net revenue for full-year 2022 expected to be approximately $132 million
·Burn Care net revenue for full-year 2022 expected to be approximately $32.5 million
·Fourth quarter MACI revenue growth expected to be approximately 24% versus prior year
·Expect tenth straight quarter with positive adjusted EBITDA and Operating Cash Flow
·As of December 31, 2022, the Company had approximately $140 million in cash and investments and no debt

 

Recent Business Highlights and Updates

 

·Following a Type C meeting with the FDA, the Company is planning to initiate a human factors validation study to support expanding the MACI label to include arthroscopic administration of MACI for the treatment of cartilage defects of the knee and now anticipates an accelerated potential commercial launch of arthroscopic MACI in 2024
·Announced FDA approval of NexoBrid® (anacaulase-bcdb) on December 28, 2022 for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns, with U.S. commercial availability expected in the second quarter of 2023
·Expect to hold a pre-IND meeting with the FDA in the first half of 2023 to discuss the MACI development program for the treatment of cartilage defects in the ankle

 

“We made tremendous progress advancing our pipeline and expanding our business in 2022, highlighted by an accelerated regulatory pathway for the MACI arthroscopic delivery program and the recent approval of NexoBrid,” said Nick Colangelo, President and CEO of Vericel. “We also had very strong MACI performance to close the year and we look forward to building on this momentum in 2023 across both of our franchises, as we expect accelerating total revenue growth this year and further acceleration in 2024 driven by a full year of NexoBrid on the market and the planned launch of arthroscopic MACI.”

 

 

 

 

Vericel is scheduled to present at the 41st Annual J.P. Morgan Healthcare Conference at 10:30 a.m. ET (7:30 a.m. PT) on Wednesday, January 11, 2023. 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 leader in advanced therapies for sports medicine and severe burn care. The Company manufactures and markets two cell therapy 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 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. © 2023 Vericel Corporation. All rights reserved.

 

Preliminary and Unaudited Nature of Reported Results

 

Our revenue expectations for the fourth quarter and full-year ended 2022, as well as our estimates concerning adjusted EBITDA, operating cash flows, 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, 2022. Accordingly, you should not place undue reliance on this preliminary estimate.

 

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 may result in differences are the inherent uncertainties associated with our expectations concerning expected revenue results for the fourth quarter and full-year ended 2022, adjusted EBITDA, operating cash flow, and estimates of our cash and investments as of December 31, 2022. Vericel’s revenue expectations for the fourth quarter and full-year ended 2022, 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 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, the ultimate timing of the commercial launch of NexoBrid in the United States, physician and burn center adoption of NexoBrid, supply chain disruptions or other events affecting MediWound Ltd.’s ability to manufacture and supply sufficient quantities of NexoBrid to meet customer demand, negative impacts on the global economy and capital markets resulting from the conflict in Ukraine, global geopolitical tensions or record inflation and the ongoing or future impacts of the COVID-19 pandemic on our business or the economy generally.

 

Page 2 of 3

 

 

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, 2021, filed with the Securities and Exchange Commission (SEC) on February 24, 2022, Vericel’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed with the SEC on November 9, 2022, 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

 

Page 3 of 3

 

Exhibit 99.2



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Advanced Therapies for the Sports Medicine & Severe Burn Care Markets 41 ST ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE JANUARY 11, 2023

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Safe Harbor 2 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 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 may result in differences are the inherent uncertainties associated with our expectations concerning expected revenue results for the fourth quarter and full - year ended 2022 , adjusted EBITDA, operating cash flow, and estimates of our cash and investments as of December 31 , 2022 .. Vericel’s revenue expectations for the fourth quarter and full - year ended 2022 , 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 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, the ultimate timing of the commercial launch of NexoBrid in the United States, physician and burn center adoption of NexoBrid , supply chain disruptions or other events affecting MediWound Ltd .. ’s ability to manufacture and supply sufficient quantities of NexoBrid to meet customer demand, negative impacts on the global economy and capital markets resulting from the conflict in Ukraine, global geopolitical tensions or record inflation and the ongoing or future impacts of the COVID - 19 pandemic on our business or the economy generally .. 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 , 2021 , filed with the Securities and Exchange Commission (SEC) on February 24 , 2022 , Vericel’s Quarterly Report on Form 10 - Q for the quarter ended September 30 , 2022 , filed with the SEC on November 9 , 2022 , 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 ..

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Vericel is a Leader in Advanced Therapies for the Sports Medicine and Severe Burn Care Markets Portfolio of Innovative Cell Therapies and Specialty Biologics with Significant Barriers to Entry 3 The leading restorative cartilage repair product in the sports medicine market The leading permanent skin replacement in the severe burn care field Focused on changing the standard of care for patients with cartilage damage and severe burns SPORTS MEDICINE SEVERE BURNS Effective and selective enzymatic agent that removes eschar while preserving viable tissue

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❶ Strong Financial Profile ❷ Maximizing MACI Growth Drivers ❸ Advancing Pipeline ❹ Expanding Burn Care Franchise ❖ High - growth cartilage repair franchise ❖ Continued growth in MACI surgeons and biopsies ❖ Strong revenue growth ❖ Positive adjusted EBITDA & Operating Cash Flow ❖ $140 M in Cash and Investments ❖ Approved 12/28/22 , commercial availability expected in Q2 2023 ❖ MACI arthroscopic study in 2023; projected launch in 2024 ❖ Pre - IND meeting for MACI Ankle planned for H1 2023 ❖ Potentially life - saving product with large market opportunity 4 Vericel is Well - Positioned to Deliver Sustained Long - Term Growth

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10 consecutive quarters with positive adjusted EBITDA & Operating Cash Flow 1 $140M in cash & investments and no debt as of 12/31/2022 1 1 Full - year 2022 revenue, adjusted EBITDA and operating cash flow, and cash and investments balances are based on preliminary una udited 2022 financial results and are subject to change. 5 2017 2018 2019 2020 2021 2022E Top - Tier Revenue Growth Sports Med Burn Care ~$164 - 165M 1 Strong Track Record of Financial Results

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2017 2018 2019 2020 2021 2022E 2023E 2024E 2025E 6 GROSS MARGIN ADJUSTED EBITDA 70%+ 30%+ 1 Based on internal and estimated long - term financial projections. Current Portfolio Plus New Product Launches Expected to Drive Strong Revenue and Profit Growth Over the Long Term + + Expect to Maintain Strong Revenue Growth Trajectory 1 Expect Continued Long - Term Margin Expansion 1 ❖ Significantly underpenetrated markets (~$3B - $4B) ❖ Limited competition with strong barriers to entry ❖ Strong reimbursement profiles ❖ Substantial operating leverage across the business ❖ Increasing margins and operating cash flow ❖ Premium - value products with concentrated call points

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> > > > > > > > TIME 7 Knee Cartilage Injuries Represent a Significant Unmet Medical Need Cartilage defects are found in ~60% of knee arthroscopies 1 ❖ Damage is caused by acute or repetitive trauma or degenerative conditions Cartilage has limited capacity for intrinsic healing and repai r ❖ 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 mon ths 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 pain 2

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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 Full - year 2022 revenue based on preliminary unaudited 2022 financial results and is subject to change. 8 Estimated Annual Addressable Patient Population (U.S.) ~315,000 2 Patients Consistent With Label ~125,000 2 Patients MD’s Consider Clinically Appropriate For MACI ~750,000 1 Cartilage Repair Procedures ~60,000 2 Patients With Larger Lesions $ 3 Billion Addressable Market in the U.S. 3 Annual Cartilage Repair Revenue $44 $68 $92 $95 $112 ~$132 $Millions 2017 2018 2019 2020 2021 2022E 4 • Mid teens % biopsy penetration • Mid single - digit % implant penetration

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MACI is the Leading Restorative Cartilage Repair Product on the Market 9 BIOPSY TAKEN CHONDROCYTES EXTRACTED, EXPANDED, & LOADED MACI DELIVERED DEFECT DEBRIDED TEMPLATE CREATED MACI IMPLANTED

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MACI Product Attributes Driving Strong Growth Since Launch 10 Broad Label with Strong Clinical Data Shorter Rehab Protocols Strong Reimbursement Profile Simpler, Less Invasive Procedure

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11 ~2,000 Surgeons Taking Biopsies in 2022 ~20% CAGR Biopsy Growth Since MACI Launch 30%+ Biopsy Conversion Rate Expected to remain a strong growth driver in 2023 Expected to remain a growth driver, with above - market growth in 2023 and over time Expected to maintain current levels in 2023 and increase to historical levels+ over time Continued Growth in 2022 Continued Growth in 2022 Stabilized in 2022 Key MACI Growth Drivers for Continued Long - Term Market Penetration

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Building a Robust and Innovative Pipeline Through Lifecycle Management and Business Development 12 Key Highlights MACI Arthroscopic Delivery ❖ Human factors study planned in 2023, with commercial launch expected in 2024 MACI Ankle Indication ❖ Pre - IND meeting with FDA planned for H1 2023 NexoBrid ❖ Approved for use in adults on December 28, 2022 1 Study design pending feedback from FDA discussions.

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13 The arthroscopic delivery of MACI is under development and neither such use, nor the sale of the MACI instruments, has been a pp roved in the United States. Novel instruments designed and developed to facilitate arthroscopic delivery Human Factors Validation Study to be initiated in 2023 Planned Launch in 2024 Overview of MACI Arthroscopic Delivery Development Program

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MACI Arthroscopic Delivery Surgical Technique 14 Click here to view an animation of the MACI arthroscopic delivery surgical technique ..

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15 High Surgeon Interest in MACI Arthro Potential for Increased MACI Volume ~90% % of target surgeons expressed Interest in arthro MACI option 1 ~90% % of current MACI users would expect to Increase MACI volume 1 Arthroscopic MACI Provides Potential Opportunity for Additional Growth Arthroscopic MACI instruments designed to treat the most common defects in the MACI TAM (2 - 4 cm 2 defects on the femoral condyles) 1 Based on Health Advances, LLC MACI market assessment report (2018).

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16 Significant Ankle Cartilage Repair Opportunity OATs MFX+ Minced allograft MFX alone OCA Minced autograft Other MACI Ankle Annual TAM Estimate (U.S.) ~66,000 2 Patients MD’s Consider Clinically Appropriate For MACI ~165,000 1 Ankle Resurfacing Procedures ~18,000 2 Larger Lesions Current Treatment Breakdown 2 MACI for the treatment of cartilage defects in the ankle represents a $1 billion 3 market opportunity ~18,000 2 Larger Lesions 1 SmartTrak Cartilage Repair Procedures; resurfacing includes microfracture, OATs, OCA, etc. and does not include chondroplasty/debrideme nt only. 2 Cello Health MACI Ankle quantitative market research survey (2021). 3 Assumes MACI ASP of $50,000+. The implantation of MACI is currently approved to be performed via an arthrotomy to the knee joint. The use of MACI in the an kle joint is under development and such use has not been approved in the United States.

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Potential MACI Ankle Indication Would Increase MACI Total Addressable Market to $4 Billion 17 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). The implantation of MACI is currently approved to be performed via an arthrotomy to the knee joint. The use of MACI in the an kle joint is under development and such use has not been approved in the United States. ~18,000 5 Larger Lesions $ 4 Billion Addressable Market in the U.S. Current MACI Knee Annual U.S. TAM (est.) ~315,000 2 Patients Consistent With Label ~125,000 2 Patients MD’s Consider Clinically Appropriate For MACI ~750,000 1 Cartilage Repair Procedures ~60,000 2 Patients With Larger Lesions MACI Ankle Annual U.S. TAM (est.) ~66,000 2 Patients MD’s Consider Clinically Appropriate For MACI ~165,000 1 Ankle Resurfacing Procedures ~18,000 2 Larger Lesions ~18,000 2 Larger Lesions $ 1 Billion Addressable Market in the U.S. $ 3 Billion Addressable Market in the U.S. 3

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18 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) 18 Burn Injury Size & 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 TREATMENT PATHWAY Epidermis Dermis Subcutaneous fat Muscle Bone Superficial (1 st Degree) Superficial Partial - Thickness (2 nd Degree) Deep Partial - Thickness (2 nd Degree) Full Thickness (3 rd Degree) Fourth Degree

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Burn Franchise Addressable Market Opportunity 19 $ 3 00 Million Addressable Market in the U.S. 4 Estimated U.S. Burn Patients 1 500,000 Annual Burns (U.S.) 1,500 Epicel - Indicated (>30% TBSA) Patients 600 Surviving >40% TBSA Patients $ 3 00 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 approval significantly expands the total addressable market opportunity for Vericel’s Burn Care franchise $ 6 00 Million Addressable Market in the U.S.

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Clear Unmet Need for an Effective and Selective Eschar Removal Agent that Preserves Viable Tissue 20 ❖ Early Eschar Removal and Burn Assessment Are Critical to Patient Healing • • Early eschar removal can reduce inflammation, stop burn progression, and reduce infections and sepsis 1,2 • Timely assessment and treatment can support improved healing and reduced scarring, reduced need for surgery and/or grafting, and improved morbidity and mortality 3,4 ❖ Current Non - Surgical Options Lack Efficacy • Current non - surgical options have limited efficacy, have not shown a statistically significant reduction in the need for surgical eschar removal, and require multiple dressing changes 6,7 ❖ Surgical Eschar Removal Can Cause Loss of Healthy Tissue • Surgical eschar removal is non - selective and causes considerable pain, blood loss, and unnecessary excision of healthy tissue 5 1. Xiao - Wu W, et al. Effects of delayed wound excision and grafting in severely burned children. Arch Surg. Sep 2002. 2. Janzekovic Z. A new concept in the early excision and immediate grafting of burns. J Trauma. Dec 1970. 3. Church D, et al. Clin Microbiol Rev. 2006;19(2):403 - 434. 4. Hirche C, et al. Burns. 2020;46(4):782 - 796. 5. Gurfinkel R, et al. Histological assessment of tangentially excised burn eschars. Can J Plast Surg. 2010. 6. Pham CH, et al. The role of collagenase ointment in acute burns: a systematic review and meta - analysis. J Wound Care. 2019; 7. Ostlie DJ, et al. Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a pr os pective randomized trial. J Pediatr Surg. Jun 2012.

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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 21 NexoBrid is Now Approved for Use in the United States ❖ 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 curve. World J Dermatol. 2017;6(2):32 - 41.

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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.

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NexoBrid Treatment Results 23 After Before Long - Term Images are for illustration and demonstration purposes only; patients will experience individualized results from the use of NexoBrid to treat severe thermal burns.

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Marketing Manufacturing Supply Chain Market Access Medical Affairs Sales 24 NexoBrid Commercialization ❖ NexoBrid is expected to be commercially available in the U.S. in Q2 2023 ❖ Key commercial activities underway • Promotional Materials Rollout • P&T Committee Engagement • Customer Training • Burn Conference Activities • Sales Team Deployment & Training

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Epicel 25 Comparison of Epicel Patient Database to National Burn Repository 1 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

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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 26 Sports Medicine Franchise Severe Burn Care Franchise ADVANCED CELL THERAPY DEVELOPMENT & MANUFACTURING PLATFORM New Advanced Cell Therapy Vertical(s)

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Growth Strategy Leverages Near - Term & Long - Term Opportunities Strong Financial Profile ❖ Continued strong revenue growth ❖ Positive adjusted EBITDA & Operating Cash Flow ❖ $140M in cash and investments Maximizing MACI Key Growth Drivers ❖ 20%+ total revenue CAGR since 2017 ❖ Focused on maximizing key growth drivers ❖ Large underpenetrated TAMs 27 Advancing Pipeline ❖ MACI arthroscopic study planned for 2023, launch expected in 2024 ❖ Pre - IND meeting for MACI Ankle planned for H1 2023 Expanding Burn Care Franchise ❖ NexoBrid approved on December 28, 2022 ❖ Launch activities underway ❖ Commercial availability expected in Q2 2023