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VCEL similar filings
- 8 May 24 Vericel Reports First Quarter 2024 Financial Results and Raises Full-Year 2024 Financial Guidance
- 3 May 24 Submission of Matters to a Vote of Security Holders
- 29 Feb 24 Vericel Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Full-Year 2024 Financial Guidance
- 9 Jan 24 Vericel Announces Preliminary Full-Year and Fourth Quarter 2023 Financial Results
- 8 Nov 23 Vericel Reports Third Quarter 2023 Financial Results and Raises Full-Year 2023 Financial Guidance
- 20 Sep 23 Vericel Announces U.S. Commercial Availability of NexoBrid® (anacaulase-bcdb) for the Treatment of Severe Thermal Burns in Adults
- 2 Aug 23 Vericel Reports Second Quarter 2023 Financial Results and Raises Full-Year 2023 Financial Guidance
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Exhibit 99.2
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Advanced Therapies for the Sports Medicine & Severe Burn Care Markets 42ND ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE JANUARY 10, 2024
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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.
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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
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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.
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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.
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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
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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.
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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.
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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
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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 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
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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
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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
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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
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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
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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
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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
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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+.
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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
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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
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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.
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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 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.
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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 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
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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
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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 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)
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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