TELA Bio, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>TELA Bio, Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations for the year ended December 31, 2023.</b>

AI Summary

TELA Bio, Inc. (TELA) filed a Annual Report (10-K) with the SEC on March 22, 2024. TELA Bio, Inc. filed its 2023 Form 10-K on March 22, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business is in Surgical & Medical Instruments & Apparatus. The company is incorporated in Delaware. The filing includes financial data for the fiscal year 2023.

Why It Matters

For investors and stakeholders tracking TELA Bio, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of TELA Bio's financial health, operational performance, and strategic initiatives for the fiscal year 2023, which is crucial for investors to assess the company's current standing and future prospects. As a public document, this filing ensures transparency and allows stakeholders, including investors, analysts, and regulators, to review the company's financial statements, risk factors, and management's discussion and analysis.

Risk Assessment

Risk Level: medium — TELA Bio, Inc. shows moderate risk based on this filing. The company operates in the medical device industry, which is subject to significant regulatory oversight and market competition, as indicated by its SIC code 3841 (Surgical & Medical Instruments & Apparatus).

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand TELA Bio's performance and potential challenges in the medical device sector.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-22 — Filing Date (Filed as of date)
• 001-39130 — SEC File Number (SEC file number)
• 24775095 — Film Number (Film number)

Key Players & Entities

• TELA Bio, Inc. (company) — Filer name
• 2023 (date) — Fiscal year end
• 1231 (date) — Fiscal year end
• 2024-03-22 (date) — Filing date
• 3841 (industry_code) — Standard Industrial Classification
• DE (state) — State of incorporation
• 1 GREAT VALLEY PARKWAY, SUITE 24 (address) — Business address
• MALVERN (city) — Business address city

FAQ

Industry Context

TELA Bio operates within the medical device industry, specifically focusing on surgical and medical instruments and apparatus (SIC 3841). This sector is characterized by innovation, regulatory hurdles, and competition.

Regulatory Implications

As a medical device company, TELA Bio is subject to regulations from bodies like the FDA. The 10-K filing will detail compliance and any regulatory risks.

What Investors Should Do

1. Analyze TELA Bio's revenue streams and growth drivers for fiscal year 2023.
2. Evaluate the company's financial health, including liquidity and debt levels, based on the 10-K statements.
3. Assess the key risks and uncertainties outlined by TELA Bio's management in the 'Risk Factors' section.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-22: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This is the initial 10-K filing for the fiscal year 2023, providing a baseline for future comparisons.

Key Financial Figures

• $0.001 — ge on which registered: Common Stock, $0.001 par value per share TELA The Nasdaq
• $1.5 billion — our OviTex products to be approximately $1.5 billion. Our OviTex portfolio consists of mult
• $700 million — OviTex PRS products to be approximately $700 million. Our OviTex products have received 510
• $5.0 million — Group, Inc. in exchange for an initial $5.0 million payment and additional future payments
• $3.0 million — yments aggregating between a minimum of $3.0 million and a maximum of $7.0 million based on
• $7.0 million — inimum of $3.0 million and a maximum of $7.0 million based on net sales of NIVIS over the ne

Filing Documents

• tela-20231231x10k.htm (10-K) — 2152KB
• tela-20231231xex10d18.htm (EX-10.18) — 24KB
• tela-20231231xex10d25.htm (EX-10.25) — 89KB
• tela-20231231xex10d31.htm (EX-10.31) — 14KB
• tela-20231231xex10d36.htm (EX-10.36) — 124KB
• tela-20231231xex21d1.htm (EX-21.1) — 5KB
• tela-20231231xex23d1.htm (EX-23.1) — 2KB
• tela-20231231xex31d1.htm (EX-31.1) — 13KB
• tela-20231231xex31d2.htm (EX-31.2) — 13KB
• tela-20231231xex32d1.htm (EX-32.1) — 7KB
• tela-20231231xex32d2.htm (EX-32.2) — 7KB
• tela-20231231xex97d1.htm (EX-97.1) — 30KB
• tela-20231231x10k001.jpg (GRAPHIC) — 78KB
• tela-20231231x10k002.jpg (GRAPHIC) — 53KB
• tela-20231231x10k003.jpg (GRAPHIC) — 2KB
• tela-20231231x10k004.jpg (GRAPHIC) — 2KB
• tela-20231231x10k006.jpg (GRAPHIC) — 3KB
• tela-20231231x10k008.jpg (GRAPHIC) — 140KB
• tela-20231231xex10d36001.jpg (GRAPHIC) — 27KB
• 0001558370-24-003782.txt (&nbsp;) — 9275KB
• tela-20231231.xsd (EX-101.SCH) — 53KB
• tela-20231231_cal.xml (EX-101.CAL) — 61KB
• tela-20231231_def.xml (EX-101.DEF) — 176KB
• tela-20231231_lab.xml (EX-101.LAB) — 525KB
• tela-20231231_pre.xml (EX-101.PRE) — 376KB
• tela-20231231x10k_htm.xml (XML) — 1238KB

BUSINESS

BUSINESS 7 ITEM 1A.

RISK FACTORS

RISK FACTORS 39 ITEM 1B. UNRESOLVED STAFF COMMENTS 78 ITEM 1C. CYBERSECURITY 78 ITEM 2.

PROPERTIES

PROPERTIES 79 ITEM 3.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 79 ITEM 4. MINE SAFETY DISCLOSURES 80 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 80 ITEM 6. [RESERVED] 80 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 81 ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 91 ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 93 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 93 ITEM 9A.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 93 ITEM 9B. OTHER INFORMATION 94 ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 94 PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 94 ITEM 11.

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 94 ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 94 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 95 ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 95 PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 95 ITEM 16. FORM 10-K SUMMARY 95 EXHIBIT INDEX 96

SIGNATURES

SIGNATURES 99 2 Table of Contents CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (this "Annual Report") and the documents incorporated by reference herein contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, we may, through our officers and other authorized representatives, make certain forward-looking statements in publicly released materials, both written and oral, including statements contained in filings with the Securities and Exchange Commission, press releases, and our communications with our stockholders. Forward-looking statements are neither statements of historical facts nor assurances of future performance, but instead discuss the future of our business, operations, future financial performance, future financial condition, plans, anticipated growth strategies, anticipated or perceived trends in our business, the industry in which we operate or the broader economy, and other objectives of management. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "predict," "positioned," "potential," "seek," "should," "target," "will," "would," the negative of such terms, and other similar expressions although not all forward-looking statements contain these identifying words. You should understand that the following important factors could affect our future results and could cause those results or other outcomes to differ materially from those expressed or implied in our forward-looking statements: estimates regarding future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing; the commercial success and degree of market acceptance of our products; the introduction of new p

BUSINESS

ITEM 1. BUSINESS Overview We are a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient's own anatomy. Our growing product portfolio is purposefully designed to leverage the patient's natural healing response while minimizing long-term exposure to permanent synthetic materials. We are committed to delivering our advanced technologies with a strong economic value proposition to assist surgeons and institutions in providing next-generation soft-tissue repair solutions to more patients worldwide. We are dedicated to building true partnerships with surgeons and healthcare providers to deliver solutions that provide both clinical and economic improvements. We believe that genuine collaboration with surgeons and healthcare providers results in the development of new solutions that empower patient care. Our first portfolio of products, the OviTex Reinforced Tissue Matrix ("OviTex"), which we first commercialized in the U.S. in July 2016 and in Europe in February 2019, addresses unmet needs in hernia repair and abdominal wall reconstruction by combining the benefits of biologic matrices and polymer materials while minimizing their shortcomings, at a cost-effective price. Hernia repair is one of the most common surgeries performed in the U.S., representing approximately 1.1 million procedures annually. Based on the volume weighted average selling price of our OviTex products, we estimate the annual U.S. total addressable market opportunity for our OviTex products to be approximately $1.5 billion. Our OviTex portfolio consists of multiple product configurations intended to address various surgical procedures within hernia repair and abdominal wall reconstruction, including ventral, inguinal, and hiatal hernia repair. In addition, we have also designed an OviTex product specifically for use in laparoscopic and robo

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View this 10-K filing on SEC EDGAR