Vericel Corp. Files 2023 Annual Report on Form 10-K

Ticker: VCEL · Form: 10-K · Filed: Feb 29, 2024 · CIK: 887359

Sentiment: neutral

Topics: 10-K, Vericel Corp, Financial Report, Biological Products, Annual Filing

TL;DR

<b>Vericel Corp. filed its 2023 10-K report detailing financial performance and business operations.</b>

AI Summary

Vericel Corp (VCEL) filed a Annual Report (10-K) with the SEC on February 29, 2024. Vericel Corp. reported its fiscal year 2023 results, ending December 31, 2023. The company's primary business is in Biological Products (No Diagnostic Substances). Vericel Corp. is incorporated in Michigan and headquartered in Cambridge, MA. The filing includes financial data for the fiscal years 2021, 2022, and 2023. Key financial statement elements like Retained Earnings, Common Stock, and Accumulated Other Comprehensive Income are detailed for these years.

Why It Matters

For investors and stakeholders tracking Vericel Corp, this filing contains several important signals. This 10-K filing provides a comprehensive overview of Vericel's financial health and strategic direction for investors and stakeholders. The detailed financial data allows for year-over-year comparisons, crucial for assessing growth trends and operational efficiency in the biological products sector.

Risk Assessment

Risk Level: medium — Vericel Corp shows moderate risk based on this filing. The filing is a standard 10-K, which is a routine annual report. However, the complexity of biological product development and market adoption introduces inherent risks.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to assess Vericel's long-term growth potential and competitive positioning.

Key Numbers

Key Players & Entities

FAQ

When did Vericel Corp file this 10-K?

Vericel Corp filed this Annual Report (10-K) with the SEC on February 29, 2024.

What is a 10-K filing?

A 10-K is a comprehensive annual financial report required by the SEC, covering audited financials, business operations, risk factors, and management discussion. This particular 10-K was filed by Vericel Corp (VCEL).

Where can I read the original 10-K filing from Vericel Corp?

You can access the original filing directly on the SEC's EDGAR system. The filing is publicly available and includes all exhibits and attachments submitted by Vericel Corp.

What are the key takeaways from Vericel Corp's 10-K?

Vericel Corp filed this 10-K on February 29, 2024. Key takeaways: Vericel Corp. reported its fiscal year 2023 results, ending December 31, 2023.. The company's primary business is in Biological Products (No Diagnostic Substances).. Vericel Corp. is incorporated in Michigan and headquartered in Cambridge, MA..

Is Vericel Corp a risky investment based on this filing?

Based on this 10-K, Vericel Corp presents a moderate-risk profile. The filing is a standard 10-K, which is a routine annual report. However, the complexity of biological product development and market adoption introduces inherent risks.

What should investors do after reading Vericel Corp's 10-K?

Review the detailed financial statements and risk factors in the 10-K to assess Vericel's long-term growth potential and competitive positioning. The overall sentiment from this filing is neutral.

Risk Factors

Key Dates

Glossary

10-K
An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (Provides investors with a detailed overview of the company's financial health and operations for the past fiscal year.)
Biological Products
Products derived from living organisms or their components, used for therapeutic or diagnostic purposes. (Defines Vericel's core industry and the regulatory and market dynamics it operates within.)

Filing Stats: 4,440 words · 18 min read · ~15 pages · Grade level 16 · Accepted 2024-02-29 09:04:36

Filing Documents

Risk Factors

Item 1A. Risk Factors 24

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 54

Cybersecurity

Item 1C. Cybersecurity 55

Properties

Item 2. Properties 56

Legal Proceedings

Item 3. Legal Proceedings 56

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 56 PART II

Market for Registrant's Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities 56

Reserved

Item 6. Reserved 58

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 59

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 68

Consolidated Financial Statements and Supplementary Data

Item 8. Consolidated Financial Statements and Supplementary Data 69

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 99

Controls and Procedures

Item 9A. Controls and Procedures 99

Other Information

Item 9B. Other Information 99

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 99 PART III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 100

Executive Compensation

Item 11. Executive Compensation 100

Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters 100

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 100

Principal Accountant Fees and Services

Item 14. Principal Accountant Fees and Services 100 PART IV

Exhibit and Financial Statement Schedules

Item 15. Exhibit and Financial Statement Schedules 101

Form 10-K Summary

Item 16. Form 10-K Summary 101 Exhibit Index 102

Signatures

Signatures 105 2 Table of Contents Cautionary Note Regarding Forward-Looking Statements This Annual Report on Form 10-K, including the documents incorporated by reference herein, contains certain statements that describe our management's beliefs concerning future business conditions, plans and prospects, growth opportunities and the outlook for our business based upon information currently available. Such statements are "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended ("Exchange Act") . Wherever possible, we have identified these forward-looking statements by words such as "will," "may," "anticipates," "believes," "intends," "estimates," "expects," "plans," "projects," "trends," "opportunity," "current," "intention," "position," "assume," "potential," "outlook," "remain," "continue," "maintain," "sustain," "seek," "target," "achieve," "continuing," "ongoing," and similar words or phrases, or future or conditional verbs such as "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, 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

Business

Item 1. Business General Information Vericel Corporation is a fully-integrated, commercial-stage biopharmaceutical company and a leading provider of advanced therapies for the sports medicine and severe burn care markets. Whether we are treating damaged cartilage or severe burns, we provide advanced therapies to repair serious injuries and restore lives. Our highly differentiated portfolio of cell therapy and specialty biologic products combines innovations in biology with medical technologies. We were among the first companies to achieve commercial success in the complex field of cell therapies with treatments that use tissue engineering to regenerate skin and healthy knee cartilage. We currently market two U.S. Food and Drug Administration ("FDA") approved autologous cell therapy products and one FDA-approved specialty biologic product in the U.S. MACI 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 is a permanent skin replacement Humanitarian Use Device ("HUD") for the treatment of adult and pediatric patients with deep-dermal or full-thickness burns comprising greater than or equal to 30 percent of total body surface area ("TBSA"). We also hold an exclusive license from MediWound Ltd. ("MediWound") for North American rights to NexoBrid (anacaulase-bcdb), a topically-administered biological orphan product containing proteolytic enzymes, which is indicated for the removal of eschar in adults with deep partial thickness and/or full thickness thermal burns. Following FDA approval, we began commercial sales of NexoBrid in the U.S. during the third quarter of 2023. Our Strategy Our objective is to become the leading developer in advanced therapies for the sports medicine and severe burn care markets. To achieve this objective, we intend to: Increase MACI revenue by increasing the number of surgeons implant

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