Elutia Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Elutia Inc. has filed its 2023 10-K report, detailing financial data and corporate history.</b>

AI Summary

ELUTIA INC. (ELUT) filed a Annual Report (10-K) with the SEC on March 11, 2024. Elutia Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The company was formerly known as Aziyo Biologics, Inc., with a name change on June 5, 2017. The filing includes data related to common stock, additional paid-in capital, and retained earnings for fiscal years 2021, 2022, and 2023. Specific financial instrument data, including common stock warrants, is detailed for various dates in 2023 and 2022. The company's principal business is in Biological Products (No Diagnostic Substances) under SIC code 2836.

Why It Matters

For investors and stakeholders tracking ELUTIA INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Elutia Inc.'s financial position and operational details for the fiscal year 2023, crucial for investors assessing the company's performance and future prospects. The inclusion of historical financial data and information on stock transactions offers context for understanding the company's capital structure and equity evolution.

Risk Assessment

Risk Level: — ELUTIA INC. shows moderate risk based on this filing. The filing is a standard annual report (10-K) and does not contain immediate, significant new risks or disclosures beyond routine financial reporting.

Analyst Insight

Review the detailed financial statements and risk factors within the 10-K to understand Elutia Inc.'s financial health and strategic direction.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-11 — Filing Date (Date of submission)
• 001-39577 — SEC File Number (SEC registration number)
• 474790334 — IRS Number (Company tax identification)

Key Players & Entities

• ELUTIA INC. (company) — Filer name
• AZIYO BIOLOGICS, INC. (company) — Former company name
• 2023-12-31 (date) — Fiscal year end
• 2024-03-11 (date) — Filing date
• 2836 (industry_code) — Standard Industrial Classification

FAQ

Industry Context

Elutia Inc. operates within the Biological Products sector, focusing on products that are not diagnostic substances.

Regulatory Implications

As a publicly traded company in the US, Elutia Inc. is subject to SEC regulations, including the requirement to file annual reports like this 10-K.

What Investors Should Do

1. Analyze the financial statements for revenue trends, profitability, and cash flow.
2. Examine the 'Risk Factors' section for potential challenges and uncertainties facing the company.
3. Review management's discussion and analysis (MD&A) for insights into business strategy and outlook.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-11: Filing Date — Date Elutia Inc. submitted its 10-K report.

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. (This filing provides the official annual financial overview of Elutia Inc.)

Common Stock Warrant

A contract that gives the holder the right, but not the obligation, to buy or sell a stock at a specific price on or before a certain date. (Details on these financial instruments are provided, impacting potential equity dilution and financial reporting.)

Year-Over-Year Comparison

This is the initial 10-K filing for Elutia Inc. under its current name, providing a baseline for future comparisons.

Key Financial Figures

• $0.001 — tered Class A Common Stock, par value $0.001 per share ELUT The Nasdaq Capital M
• $2.36 — 4,959,655 based on the closing price of $2.36 of the registrant's Class A common stoc
• $14.6 m — In the sale, we received approximately $14.6 million, and we may earn up to an additio
• $20 m — on, and we may earn up to an additional $20 million, in the aggregate, in the form of
• $1 billion — ined market opportunity of greater than $1 billion in the United States, will continue to

Filing Documents

• elut-20231231x10k.htm (10-K) — 2936KB
• elut-20231231xex23d1.htm (EX-23.1) — 5KB
• elut-20231231xex31d1.htm (EX-31.1) — 13KB
• elut-20231231xex31d2.htm (EX-31.2) — 13KB
• elut-20231231xex32d1.htm (EX-32.1) — 8KB
• elut-20231231xex32d2.htm (EX-32.2) — 8KB
• elut-20231231xex97.htm (EX-97) — 34KB
• elut-20231231xex97001.jpg (GRAPHIC) — 5KB
• 0001558370-24-002864.txt (&nbsp;) — 11440KB
• elut-20231231.xsd (EX-101.SCH) — 78KB
• elut-20231231_cal.xml (EX-101.CAL) — 86KB
• elut-20231231_def.xml (EX-101.DEF) — 390KB
• elut-20231231_lab.xml (EX-101.LAB) — 731KB
• elut-20231231_pre.xml (EX-101.PRE) — 590KB
• elut-20231231x10k_htm.xml (XML) — 1656KB

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS 1 TRADEMARKS, TRADE NAMES AND SERVICE MARKS 2 INDUSTRY AND OTHER DATA 2 RISK FACTORS SUMMARY 2 PART I 3 Item 1.

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 26 Item 1B. Unresolved Staff Comments 77 Item 1C. Cybersecurity 77 Item 2.

Properties

Properties 78 Item 3.

Legal Proceedings

Legal Proceedings 78 Item 4. Mine Safety Disclosure 78 PART II 78 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 78 Item 6. [Reserved] 79 Item 7.

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 79 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 95 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 96 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 96 Item 9A.

Controls and Procedures

Controls and Procedures 96 Item 9B. Other Information 97 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 97 PART III 97 Item 10. Directors, Executive Officers and Corporate Governance 97 Item 11.

Executive Compensation

Executive Compensation 97 Item 12.

Security Ownership of Certain Beneficial Owners and Management Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management Related Stockholder Matters 97 Item 13. Certain Relationships and Related Transactions, and Director Independence 98 Item 14. Principal Accountant Fees and Services 98 PART IV 98 Item 15. Exhibits and Financial Statement Schedules 98 Item 16. Form 10-K Summary 105

SIGNATURES

SIGNATURES 106 INDEX TO FINANCIAL STATEMENTS F-1 i Table of Contents

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (the "Annual Report") contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements other than statements of historical facts contained in this Annual Report, including, without limitation, statements regarding our results of operations, financial position, and business strategy; expectations regarding our products and their targeted effects; plans for our sales and marketing growth; expectations regarding our recently completed sale of our Orthobiologics Business to Berkeley Biologics, LLC ("Berkeley"), including potential payment of post-closing earnout payments; our anticipated expansion of our product development and research activities; increases in expenses and seasonality; expectations regarding our competitive advantages, and overall clinical and commercial success; expectations regarding the pending lawsuits and claims related to our recall of a single lot of Fiber Viable Bone Matrix ("FiberCel"), amounts recoverable under insurance, indemnity and contribution agreements and the impact of such lawsuits and claims on our future financial position; expectations regarding the potential emergence of lawsuits, claims and regulatory findings related to our recall of a single lot of the viable bone matrix ("VBM") products, amounts recoverable under insurance, indemnity and contribution agreements and the impact of such lawsuits and claims on our future financial position; our expectations and plans regarding pursuit of any strategic transactions; and our expectations relating to the U.S. Food and Drug Administration ("FDA") regulatory process for the

Business

Item 1. Business. Overview At Elutia, our mission is to humanize medicine so that patients can thrive without compromise. As a commercial-stage company, we seek to leverage our unique understanding of biologics to improve the interaction between implanted medical devices and patients by reducing complications associated with these surgeries. These complications include device migration, erosion, non-union of implants as well as implant rejection. In addition, our products are designed to mitigate the formation of scar and fibrotic capsule formation that commonly occurs with device implants and is linked with additional risk factors including infection and capsular contracture. We are dedicated to supporting patients by providing physicians with a consistent product of uniform material, thus enabling surgeons to focus on achieving successful outcomes for complex procedures. We estimate that, over the past two years, more than 600,000 surgical procedures were performed per year in the United States in which the patient was implanted with medical devices such as pacemakers, defibrillators, neuro-stimulators or tissue expanders for breast reconstruction. This number has been driven by advances in medical device technologies, reimbursement models focused on patient outcomes, and an aging population with a growing incidence of comorbidities, including diabetes, obesity and cardiovascular and peripheral vascular diseases. These comorbidities can exacerbate various immune responses and contribute to other complications upon device implant. Our products are targeted to address unmet clinical needs with the goal of promoting healthy tissue formation and avoiding complications associated with medical device implants, such as scar tissue formation, capsular contraction, erosion, migration and implant rejection. These products currently focus on our priority markets – Device Protection and Women's Health. In Device Protection, we sell CanGaroo, a "first-to-market" biological

View Full Filing

View this 10-K filing on SEC EDGAR