ESTABLISHMENT LABS HOLDINGS INC. Files 2023 Annual Report (10-K)

Ticker: ESTA · Form: 10-K · Filed: Mar 4, 2024 · CIK: 1688757

Establishment Labs Holdings Inc. 10-K Filing Summary
FieldDetail
CompanyEstablishment Labs Holdings Inc. (ESTA)
Form Type10-K
Filed DateMar 4, 2024
Risk Levelmedium
Pages15
Reading Time18 min
Key Dollar Amounts$50 million, $12.6 million, $51.7 million, $84.6 million, $225 m
Sentimentneutral

Sentiment: neutral

Topics: 10-K, Annual Report, Establishment Labs, Medical Devices, Financials

TL;DR

<b>Establishment Labs Holdings Inc. has filed its 2023 10-K annual report detailing its financial performance and business operations.</b>

AI Summary

ESTABLISHMENT LABS HOLDINGS INC. (ESTA) filed a Annual Report (10-K) with the SEC on March 4, 2024. Establishment Labs Holdings Inc. filed its 2023 10-K report on March 4, 2024. The company is incorporated in D8 and its fiscal year ends on December 31. Its principal business address is Building B15 and 25 Coyol Free Zone, Alajuela, G2, 20101. The SIC code for the company is 3842 (Orthopedic, Prosthetic & Surgical Appliances & Supplies). The filing covers the fiscal year ending December 31, 2023.

Why It Matters

For investors and stakeholders tracking ESTABLISHMENT LABS HOLDINGS INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of the company's financial health, operational strategies, and risk factors for the fiscal year 2023, which is crucial for investors to assess its current standing and future prospects. The report includes detailed financial statements, management's discussion and analysis, and risk disclosures, offering insights into the company's performance in the orthopedic, prosthetic, and surgical appliances sector.

Risk Assessment

Risk Level: medium — ESTABLISHMENT LABS HOLDINGS 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 and the nature of its business.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Establishment Labs' performance and potential challenges in the coming fiscal year.

Key Numbers

  • 2023-12-31 — Fiscal Year End (Conformed Period of Report)
  • 2024-03-04 — Filing Date (As of Date)
  • 2023-01-01 — Fiscal Year Start (Reporting period start date)
  • 2022-12-31 — Prior Year End (Comparison period)

Key Players & Entities

  • ESTABLISHMENT LABS HOLDINGS INC. (company) — Filer name
  • 0001688757 (company) — Central Index Key
  • 3842 (company) — Standard Industrial Classification
  • 981436377 (company) — IRS Number
  • D8 (company) — State of Incorporation
  • 20101 (company) — Business ZIP Code
  • 50624342400 (company) — Business Phone
  • 001-38593 (company) — SEC File Number

FAQ

When did ESTABLISHMENT LABS HOLDINGS INC. file this 10-K?

ESTABLISHMENT LABS HOLDINGS INC. filed this Annual Report (10-K) with the SEC on March 4, 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 ESTABLISHMENT LABS HOLDINGS INC. (ESTA).

Where can I read the original 10-K filing from ESTABLISHMENT LABS HOLDINGS INC.?

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 ESTABLISHMENT LABS HOLDINGS INC..

What are the key takeaways from ESTABLISHMENT LABS HOLDINGS INC.'s 10-K?

ESTABLISHMENT LABS HOLDINGS INC. filed this 10-K on March 4, 2024. Key takeaways: Establishment Labs Holdings Inc. filed its 2023 10-K report on March 4, 2024.. The company is incorporated in D8 and its fiscal year ends on December 31.. Its principal business address is Building B15 and 25 Coyol Free Zone, Alajuela, G2, 20101..

Is ESTABLISHMENT LABS HOLDINGS INC. a risky investment based on this filing?

Based on this 10-K, ESTABLISHMENT LABS HOLDINGS INC. presents a moderate-risk profile. The company operates in the medical device industry, which is subject to significant regulatory oversight and market competition, as indicated by its SIC code and the nature of its business.

What should investors do after reading ESTABLISHMENT LABS HOLDINGS INC.'s 10-K?

Investors should review the detailed financial statements and risk factors in the 10-K to understand Establishment Labs' performance and potential challenges in the coming fiscal year. The overall sentiment from this filing is neutral.

Risk Factors

  • Geographic Concentration Risk [medium — market]: The company faces geographic concentration risk, particularly in Brazil, as evidenced by revenue data for 2021, 2022, and 2023.

Key Dates

  • 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
  • 2024-03-04: Filing Date — Date the 10-K report was officially submitted to the SEC.

Filing Stats: 4,479 words · 18 min read · ~15 pages · Grade level 14 · Accepted 2024-03-04 08:09:07

Key Financial Figures

  • $50 million — nts for gross proceeds of approximately $50 million. See Note 15 "Subsequent Events" for ad
  • $12.6 million — d cold shell building for approximately $12.6 million in 2022. In July 2023, we announced the
  • $51.7 million — units per year. We estimate a total of $51.7 million in costs for this initial phase of our
  • $84.6 million — ering for net proceeds of approximately $84.6 million. In February 2023, we submitted the fi
  • $225 m — an aggregate principal amount of up to $225 million, with Oaktree Fund Administration
  • $150 million — tranche were advanced in the amount of $150 million and $25 million in April and December 2
  • $25 million — anced in the amount of $150 million and $25 million in April and December 2022, respectivel
  • $65 million — used to repay in full and terminate the $65 million in aggregate principal amount outstandi
  • $6.5 million — or the Madryn Credit Agreement, and the $6.5 million early repayment penalty. In February 20
  • $0.6 billion — o 2030. The market, currently valued at $0.6 billion in 2022, is projected to exceed $1 bill
  • $1 billion — billion in 2022, is projected to exceed $1 billion by 2030. This growth is expected to be

Filing Documents

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 30 Item 1B. Unresolved Staff Comments 69 Item 1C . Cybersecurity 69 Item 2.

Properties

Properties 70 Item 3.

Legal Proceedings

Legal Proceedings 70 Item 4. Mine Safety Disclosures 70 PART II 70 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 70 Item 6. Reserved 71 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 71 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 83 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 83 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 83 Item 9A.

Controls and Procedures

Controls and Procedures 84 Item 9B. Other Information 88 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 88 PART III 88 Item 10. Directors, Executive Officers, and Corporate Governance 88 Item 11.

Executive Compensation

Executive Compensation 88 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 88 Item 13. Certain Relationships and Related Transactions and Director Independence 88 Item 14. Principal Accountant Fees and Services 88 PART IV 88 Item 15. Exhibit and Financial Statement Schedules 88 Item 16. Form 10-K Summary 90

Signatures

Signatures i EXPLANATORY NOTE In this report, unless the context indicates otherwise, the terms "Establishment Labs," "Company," "we", "us" and "our" refer to Establishment Labs Holdings Inc., a British Virgin Islands entity, and its consolidated subsidiaries. We own, or have rights to, trademarks and trade names that we use in connection with the operation of our business, including Establishment Labs and our logo as well as other brands such as Motiva Implants, SilkSurface/SmoothSilk, VelvetSurface, ProgressiveGel, TrueMonobloc, BluSeal, Divina, Ergonomix, Ergomonix2, Ergonomix2 Diamond, Mia Femtech, MotivaImagine and Zen, among others. Other trademarks and trade names appearing in this report are the property of their respective owners. Solely for your convenience, some of the trademarks and trade names referred to in this report are listed without the and TM symbols, but we will assert, to the fullest extent under applicable law, our rights to our trademarks and trade names. WEBSITE REFERENCES In this Annual Report on Form 10-K, we make references to our website at establishmentlabs.com. References to our website through this Form 10-K are provided for convenience only and the content on our website does not constitute a part of, and shall not be deemed incorporated by reference into, this Annual Report on Form 10-K. SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended or the Exchange Act. You can find many (but not all) of these statements by looking for words such as "approximates," "believes," "expects," "anticipates," "estimates," "intends," "plans," "would," "may" or other similar expressions in this report. Any statements that refer to projections of our future financial or operating performance, our liquidity and anticipated cash plans, anticipated trends in o

BUSINESS

ITEM 1. BUSINESS Overview We are a medical technology company focused on improving patient safety and aesthetic outcomes, initially in the breast aesthetics and reconstruction market. We initially incorporated in Costa Rica in 2004 and subsequently reorganized under a parent holding company in the British Virgin Islands in 2013. Our line of silicone gel-filled breast implants, branded as Motiva Implants, is the centerpiece of our medical technology platform. Our post-market surveillance data (which was not generated in connection with a United States Food and Drug Administration, or FDA, pre-market approval, or PMA, study collected at defined follow-ups, but was patient or practitioner reported) and published third-party registries and data indicate that Motiva Implants have low rates of adverse events (including rupture, capsular contracture, and safety related reoperations) that we believe compare favorably with those of our competitors. We believe the proprietary technologies that differentiate our Motiva Implants enable improved safety and aesthetic outcomes and drive our revenue growth. We have developed other complementary products and services, which are aimed at further enhancing patient outcomes. Since launching Motiva Implants in October 2010, the majority of our revenue has been generated from sales of our Motiva Implants. To date, our Motiva Implants are registered to be sold in 86 countries, including, most recently, in China. We currently sell our products via exclusive distributors or our direct sales force and have introduced five generations of Motiva Implants. We currently commercially sell five product families: (i) Round and Ergonomix Round, (ii) Ergonomix Oval, (iii) Anatomical TrueFixation, (iv) Ergonomix2 Round and Ergonomix2 Diamond and (v) Flora Tissue Expander. Our products incorporate first of-its-kind safety features including: (i) SmoothSilk / SilkSurface (an optimized biocompatible advanced smooth surface that is designed to reduce

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