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ESTA on Nasdaq

ESTABLISHMENT LABS HOLDINGS INC.

In its 2026 annual report the company says: “We are a global medical technology company focused on improving patient safety and aesthetic outcomes, initially in the breast aesthetics and reconstruction market. Our line of silicone gel-filled breast implants, branded as Motiva Implants, is the centerpiece of our medical technology platform.”5 It is headquartered in Alajuela, Costa Rica.2 Its shares trade on Nasdaq under the symbol ESTA.2

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Last updated Oct 21, 2026.

Overview

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  • TickerESTA on Nasdaq2
  • IndustryOrthopedic, Prosthetic & Surgical Appliances & Supplies2
  • HeadquartersAlajuela, Costa Rica2
  • Incorporated inVirgin Islands, British3
  • Business addressBuilding B15 And 25 Coyol Free Zone, Alajuela, G2 201013
  • Filer categoryLarge accelerated filer3
  • Legal formCorporation2
  • LEI549300BCBQ714JNJ7V582
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressPO Box 3140, VG1110 Road Town, British Virgin Islands2

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We are a global 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 in 2013 under a parent holding company in the British Virgin Islands.5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

69.3%Gross margin6
-18.5%Operating margin6
-24.2%Net margin6
27.1%Revenue growth, 20256
-216.9%Return on equity6
10.51×Debt to equity6
-$56.9MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue25¢$64.8M
  • Research and development8¢$20.2M
  • Selling, general and admin64¢$165.1M
  • Income tax3¢$7.0M

Out of $211.1M in revenue.6 The company lost money this year.

Financial statements

Revenue789106$211.1M in 2025+136% since 2019
0$100.0M$200.0M$300.0M2019: $89.6M$89.6M20192020: $84.7M$84.7M2020−5%2021: $126.7M$126.7M2021+50%2022: $161.7M$161.7M2022+28%2023: $165.2M$165.2M2023+2%2024: $166.0M$166.0M2024+1%2025: $211.1M$211.1M2025+27%
Gross profit789106$146.3M in 2025+167% since 2019
0$50.0M$100.0M$150.0M2019: $54.9M$54.9M20192020: $52.5M$52.5M2020−4%2021: $85.4M$85.4M2021+63%2022: $106.6M$106.6M2022+25%2023: $107.0M$107.0M2023+0%2024: $109.5M$109.5M2024+2%2025: $146.3M$146.3M2025+34%
Operating income789106-$39.0M in 2025+26% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$30.9M-$30.9M20192020: -$27.9M-$27.9M2020−10%2021: -$25.1M-$25.1M2021−10%2022: -$39.7M-$39.7M2022+58%2023: -$65.0M-$65.0M2023+64%2024: -$50.0M-$50.0M2024−23%2025: -$39.0M-$39.0M2025−22%
Net income789106-$51.1M in 2025+34% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M02019: -$38.1M-$38.1M20192020: -$38.1M-$38.1M2020−0%2021: -$41.1M-$41.1M2021+8%2022: -$75.2M-$75.2M2022+83%2023: -$78.5M-$78.5M2023+4%2024: -$84.6M-$84.6M2024+8%2025: -$51.1M-$51.1M2025−40%
Fiscal year2019202020212022202320242025
Revenue$89.6M7$84.7M8$126.7M9$161.7M10$165.2M6$166.0M6$211.1M6
Cost of revenue$34.7M7$32.2M8$41.3M9$55.1M10$58.2M6$56.5M6$64.8M6
Gross profit$54.9M7$52.5M8$85.4M9$106.6M10$107.0M6$109.5M6$146.3M6
Research and development$15.0M7$13.8M8$18.3M9$20.3M10$26.4M6$19.7M6$20.2M6
Selling, general and admin$70.8M7$66.6M8$92.2M9$126.0M10$145.6M6$139.8M6$165.1M6
Operating expenses$110.5M9$146.3M10$172.0M6$159.5M6$185.3M6
Operating income-$30.9M7-$27.9M8-$25.1M9-$39.7M10-$65.0M6-$50.0M6-$39.0M6
Interest$8.7M7$9.4M8$9.1M9$11.8M9$15.4M9
Income before tax-$39.7M9-$72.8M10-$78.6M6-$84.6M6-$58.0M6
Income tax$640.0K7$104.0K8$1.4M9$2.4M10-$81.0K6-$32.0K6-$7.0M6
Net income-$38.1M7-$38.1M8-$41.1M9-$75.2M10-$78.5M6-$84.6M6-$51.1M6
Earnings per share-$1.867-$1.638-$1.729-$3.0810-$3.076-$3.006-$1.726
Earnings per share (diluted)-$1.867-$1.638-$1.729-$3.0810-$3.076-$3.006-$1.726
Shares (weighted, basic)24.0M shares924.5M shares1025.6M shares628.2M shares629.6M shares6
Shares (weighted, diluted)24.0M shares924.5M shares1025.6M shares628.2M shares629.6M shares6

Compare ESTABLISHMENT LABS HOLDINGS INC. with another company

Corporate structure

ESTABLISHMENT LABS HOLDINGS INC. sits at the top of its group. 16 entities, 13 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of ESTABLISHMENT LABS HOLDINGS INC.

  • JW Asset Management, LLC Filed SCHEDULE 13G on ESTABLISHMENT LABS HOLDINGS INC., latest Jul 31, 2026
  • BlackRock Filed SCHEDULE 13G on ESTABLISHMENT LABS HOLDINGS INC., latest Jul 28, 2026
  • BROWN ADVISORY INC Filed SCHEDULE 13G/A on ESTABLISHMENT LABS HOLDINGS INC., latest May 15, 2026 (6 filings since Feb 7, 2022)
  • Quiros Juan Jose Chacon Filed SCHEDULE 13G/A on ESTABLISHMENT LABS HOLDINGS INC., latest Feb 19, 2026 (5 filings since Feb 1, 2022)
  • Nantahala Capital Management, LLC Filed SCHEDULE 13G/A on ESTABLISHMENT LABS HOLDINGS INC., latest Feb 13, 2026 (7 filings since Feb 14, 2022)
  • Capital Research Global Investors Filed SCHEDULE 13G/A on ESTABLISHMENT LABS HOLDINGS INC., latest Aug 13, 2025 (3 filings since Nov 12, 2024)
  • Qatar Investment Authority Filed SCHEDULE 13G/A on ESTABLISHMENT LABS HOLDINGS INC., latest May 13, 2025 (2 filings since Nov 12, 2024)
  • RTW INVESTMENTS, LP Filed SCHEDULE 13G/A on ESTABLISHMENT LABS HOLDINGS INC., latest Feb 14, 2025 (4 filings since Feb 14, 2022)
  • PURA VIDA INVESTMENTS, LLC Filed SC 13G/A on ESTABLISHMENT LABS HOLDINGS INC., latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • ESTABLISHMENT LABS HOLDINGS INC. Alajuela, Costa Rica
    • Establishment Labs Produtos par Saude Ltda Subsidiary · Brazil
    • Establishment Labs, S.A. Subsidiary · Costa Rica
    • European Distribution Center Motiva BV Subsidiary · Belgium
    • JAMM Technologies, Inc. Subsidiary · Delaware, United States
    • Motiva Argentina S.R.L. Subsidiary · Argentina
    • Motiva Austria GmbH Subsidiary · Austria
    • Motiva Benelux BV Subsidiary · Belgium
    • Motiva Germany GmbH Subsidiary · Germany
    • Motiva Implants France SAS Subsidiary · France
    • Motiva Implants Spain, S.L. Subsidiary · Spain
    • Motiva Implants UK Limited Subsidiary · United Kingdom
    • Motiva Italy S.R.L Subsidiary · Italy
    • Motiva NL BV Subsidiary · Netherlands
    • Motiva Nordica AB Subsidiary · Sweden
    • Motiva USA, LLC Subsidiary · Delaware, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What ESTABLISHMENT LABS HOLDINGS INC. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$101.8M6 Dec 31, 2025$98.1M6 Dec 31, 2024+3.8%
Accumulated depreciation$26.2M6 Dec 31, 2025$20.1M6 Dec 31, 2024+30.3%
Property and equipment, net$75.6M6 Dec 31, 2025$78.0M6 Dec 31, 2024−3.1%
Operating-lease assets (leased space)$4.3M6 Dec 31, 2025$5.6M6 Dec 31, 2024−22.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$75.6M6 Dec 31, 2025$90.3M6 Dec 31, 2024−16.4%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$1.2M6 Dec 31, 2025$1.2M6 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$9.9M6 Dec 31, 2025$11.7M6 Dec 31, 2024−14.9%
Accumulated amortization$11.8M6 Dec 31, 2025$8.8M6 Dec 31, 2024+34.0%
Finite-lived intangibles, net$9.3M6 Dec 31, 2025$11.0M10 Dec 31, 2024−15.4%

Inventory

ItemLatestA year beforeChange
Inventory, total$85.6M6 Dec 31, 2025$78.8M6 Dec 31, 2024+8.7%
Raw materials$35.2M6 Dec 31, 2025$41.3M6 Dec 31, 2024−14.9%
Work in process$2.8M6 Dec 31, 2025$2.5M6 Dec 31, 2024+15.8%
Finished goods$47.6M6 Dec 31, 2025$35.0M6 Dec 31, 2024+36.0%

Properties, in its own words

Our main executive facilities, which include over 200,000 square feet of office, laboratory, and manufacturing space, are situated in Alajuela, Costa Rica. We also lease office or warehouse spaces in numerous locations worldwide such as Wommelgem, Belgium; Sao Paulo and Rio de Janeiro, Brazil; Stockholm, Sweden; Barcelona, Spain; Rome, Italy; Addison and Austin, Texas, USA; Santa Barbara, California, USA; London, England; Haar, Germany; Cavaillon, France; and Buenos Aires, Argentina, with leases expiring from 2025 to 2031.

Item 2 of the 10-K filed Feb 27, 2026.5

Leadership

Who has led ESTABLISHMENT LABS HOLDINGS INC., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Quiros Juan Jose Chacon2018–2024
  2. Filippo Caldini2025–now

President

  1. Filippo Caldini2024

Chief financial officer

  1. Renee Gaeta2018–2021
  2. Raj Denhoy2021–2026
  3. Cassandra Harris2026–now

Chief operating officer

  1. Santos Salvador Dada2018–2021
  2. Paul D. Rodio2022–2023
20202025
Board members and other officers (16)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorJuan Jose Chacon-Quiros named Jan 24, 202437
  • Executive OfficerRoss Mansbach named Jan 24, 202437

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Establishment Labs Produtos par Saude Ltda Brazil4
  • Establishment Labs, S.A. Costa Rica4
  • European Distribution Center Motiva BV Belgium4
  • JAMM Technologies, Inc. Delaware4
  • Motiva Argentina S.R.L. Argentina4
  • Motiva Austria GmbH Austria4
  • Motiva Benelux BV Belgium4
  • Motiva Germany GmbH Germany4
  • Motiva Implants France SAS France4
  • Motiva Implants Spain, S.L. Spain4
  • Motiva Implants UK Limited The United Kingdom4
  • Motiva Italy S.R.L Italy4
  • Motiva NL BV Netherlands4
  • Motiva Nordica AB Sweden4
  • Motiva USA, LLC Delaware4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Oct 15, 20268-K Entered a material agreement38
  2. Aug 6, 20268-K Results of operations39
  3. Jun 29, 20268-K Executive or director change; Regulation FD disclosure40
  4. May 22, 20268-K Shareholder vote41
  5. May 6, 20268-K Results of operations42
  6. Apr 30, 20268-K Entered a material agreement; New debt or obligation43
  7. Feb 24, 20268-K Results of operations44
  8. Jan 14, 20268-K Regulation FD disclosure45
  9. Jan 12, 20268-K Results of operations46
  10. Nov 5, 20258-K Results of operations47
  11. Oct 3, 20258-K Entered a material agreement; New debt or obligation48
  12. Aug 7, 20258-K Results of operations49
  13. Mar 20, 2025New chief executive Filippo Caldini becomes CEO14
  14. Jul 18, 2018New chief executive Quiros Juan Jose Chacon becomes CEO15

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.38) a share, on Nov 5, 2025.50

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results39
  2. May 6, 2026Reported quarterly or annual results42
  3. Feb 24, 2026Reported quarterly or annual results44
  4. Jan 12, 2026Reported quarterly or annual results46
  5. Nov 5, 2025Reported quarterly or annual results47
  6. Aug 7, 2025Reported quarterly or annual results49
  7. May 7, 2025Reported quarterly or annual results51
  8. Apr 10, 2025Reported quarterly or annual results52

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

347 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 63 major events, 201 insider forms, 31 large holders, 1 private raises, 31 other. The latest 20:

  1. Oct 15, 20268-K EDGAR
  2. Oct 2, 20264 EDGAR
  3. Oct 2, 20264 EDGAR
  4. Oct 2, 20264 EDGAR
  5. Oct 2, 20264 EDGAR
  6. Oct 2, 20264 EDGAR
  7. Aug 26, 20264 EDGAR
  8. Aug 7, 202610-Q EDGAR
  9. Aug 6, 20268-K EDGAR
  10. Jul 31, 2026SCHEDULE 13G EDGAR
  11. Jul 28, 2026SCHEDULE 13G EDGAR
  12. Jul 10, 20264 EDGAR
  13. Jul 10, 20264 EDGAR
  14. Jul 1, 20264 EDGAR
  15. Jul 1, 20264 EDGAR
  16. Jul 1, 20264 EDGAR
  17. Jul 1, 20264/A EDGAR
  18. Jul 1, 20264 EDGAR
  19. Jul 1, 20264 EDGAR
  20. Jun 29, 20264 EDGAR

The 347 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

43 open-market trades by officers, directors and large owners since October 2021: 18 buys and 25 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 28, 2026JW Partners, LPSale65,100$72.89$4.7MForm 4
May 27, 2026JW Partners, LPSale113$72.50$8.2KForm 4
May 26, 2026JW Partners, LPSale25,320$74.39$1.9MForm 4
May 21, 2026JW GP, LLCSale16,999$71.40$1.2MForm 4
May 20, 2026JW GP, LLCSale3,580$70.56$252.6KForm 4
May 6, 2026Chacon Quiros Juan JoseDirectorSale105,000$75.42$7.9MForm 4
May 6, 2026JW Asset Management, LLCSale60,000$75.63$4.5MForm 4
May 4, 2026Chacon Quiros Juan JoseDirectorSale7,751$70.48$546.3KForm 4
May 1, 2026Chacon Quiros Juan JoseDirectorSale67,249$70.78$4.8MForm 4
Apr 27, 2026Chacon Quiros Juan JoseDirectorSale2,180$66.26$144.4KForm 4
Apr 24, 2026Chacon Quiros Juan JoseDirectorSale30,178$65.78$2.0MForm 4
Apr 23, 2026Chacon Quiros Juan JoseDirectorSale42,642$65.43$2.8MForm 4
Apr 14, 2026Chacon Quiros Juan JoseDirectorSale37,500$65.23$2.4MForm 4
Mar 25, 2026Chacon Quiros Juan JoseDirectorSale3,575$60.08$214.8KForm 4
Mar 23, 2026Chacon Quiros Juan JoseDirectorSale33,925$60.39$2.0MForm 4
Nov 10, 2025JW Opportunities Fund, LLCSale11,000$67.07$737.8KForm 4
Nov 7, 2025JW Asset Management, LLCSale2,500$65.09$162.7KForm 4
Nov 6, 2025Wild Jason G.Sale7,591$65.00$493.4KForm 4
Aug 14, 2025LEWIN NICHOLAS SHERIDANDirectorBuy2,600$37.85$98.4KForm 4
Aug 13, 2025LEWIN NICHOLAS SHERIDANDirectorBuy2,300$34.30$78.9KForm 4

All 43 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Filippo "Peter" CaldiniChief Executive Officer$528.8K$2.9M62
2025Juan José Chacón QuirósFormer Chief Executive Officer$218.9K$1.7M62
2025Rajbir S. DenhoyFormer Chief Financial Officer$370.0K$1.4M62
2025S. Ross MansbachGeneral Counsel and Chief Compliance Officer$352.0K$1.1M62
2024Juan José Chacón QuirósFormer Chief Executive Officer$733.6K$2.6M62
2024Filippo "Peter" CaldiniChief Executive Officer$152.0K$1.2M62
2024Rajbir S. DenhoyFormer Chief Financial Officer$369.4K$1.1M62
2024S. Ross MansbachGeneral Counsel and Chief Compliance Officer$358.8K$1.1M62
2023Juan José Chacón QuirósFormer Chief Executive Officer$668.0K$2.4M62
2023Rajbir S. DenhoyFormer Chief Financial Officer$364.6K$1.1M62
2023S. Ross MansbachGeneral Counsel and Chief Compliance Officer$352.9K$1.0M62

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Jan 9, 2024Raised $50 million in a private offering of equity Form D: 10 investors so far Form D

SEC filer profile

How ESTABLISHMENT LABS HOLDINGS INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARESTABLISHMENT LABS HOLDINGS INC.1
  • CIK0001688757
  • Employer ID (EIN)98-14363775
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inBritish Virgin Islands5
  • Fiscal year endsDecember 311
  • Industry code (SIC)3842 Orthopedic, Prosthetic & Surgical Appliances & Supplies1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business addressBuilding B15 And 25 Coyol Free Zone, Alajuela, G2 201011
  • Phone506243424001
  • Shares outstanding29,801,891 as of Aug 6, 202612
  • Public float$975.1M as of Jun 30, 20255
  • AuditorCBIZ CPAs P.C., Los Angeles, California PCAOB ID 199; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceFeb 2, 20171
  • Filings553 in all: 4 (266), 8-K (100), 10-Q (25), 3 (24), SC 13G/A (19), SC 13G (14), SCHEDULE 13G/A (12), 4/A (11)1
    All 35 form types

    S-8 (9), 10-K (8), DEF 14A (8), DEFA14A (8), CORRESP (7), 424B5 (5), UPLOAD (5), 144 (3), ARS (3), D (3), S-1/A (3), SCHEDULE 13G (3), CT ORDER (2), EFFECT (2), 10-K/A (1), 10-Q/A (1), 424B4 (1), 424B7 (1), 8-A12B (1), CERT (1), DRS (1), NT 10-K (1), PRE 14A (1), S-1 (1), S-1MEF (1), S-3 (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Feb 27, 2026
    Quarterly report (10-Q) Aug 7, 2026
    Proxy statement (DEF 14A) Apr 10, 2026
    Latest 8-K (8-K) Oct 15, 2026

Securities registered for trading

ClassSymbolExchange
Common Shares, No Par ValueESTANasdaq

From the cover page of the 10-K filed Feb 27, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks ESTABLISHMENT LABS HOLDINGS INC. names in Item 1A of its 10-K filed Feb 27, 2026: 68 risks under these headings, as written.5

  • Risks Related to the Development and Commercialization of Our Products
  • We have a limited operating history in the United States and may face difficulties encountered by companies early in their commercialization in competitive and rapidly evolving markets.
  • Our success depends, in part, on our ability to continue to enhance our existing products and services and develop or commercialize new products and services that respond to customer needs and preferences, which we expect will require us to incur significant expenses.
  • Changes in funding or disruptions at the FDA and other government agencies caused by funding shortages could prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Any future distribution or commercialization agreements we may enter into with respect to our current or planned products may place the development of these products outside our control or may otherwise be on terms unfavorable to us.
  • If we are unable to educate clinicians on the safe, effective and appropriate use of our products and designed surgeries, we may experience unsatisfactory patient outcomes, negative publicity and increased claims of product liability and may be unable to achieve our expected growth.
  • Commercial success of Motiva Implants in the United States or elsewhere depends on our ability to accurately forecast customer demand, manufacture sufficient quantities of product in the implant sizes that patients and physicians request, and manage inventory effectively, and the failure to do so could
  • have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • Risks Related to Our Business, Industry and Operations
  • We have incurred losses to date, and our ability to achieve and maintain profitability depends on the commercial success of our Motiva Implants.
  • Unfavorable global economic and political conditions, including slower growth or recession, inflation, decreases in consumer spending power or confidence or trade wars, have in the past, and could in the future, adversely affect our business, financial condition or results of operations.
  • If our available cash resources and anticipated cash flow from operations are insufficient to satisfy our liquidity requirements, we may seek to sell equity or convertible debt securities, enter into a credit facility or another form of third-party funding, or seek other debt financing.
The other 58 risks
  • Our business depends on maintaining our brand and ongoing customer demand for our products and services, and a significant reduction in sentiment or demand could affect our results of operations.
  • If we fail to compete effectively against our competitors, many of whom have greater resources than we have, our revenues and results of operations may be negatively affected.
  • Pricing pressure from customers and our competitors may impact our ability to sell our products at prices necessary to support our current business strategies and future expansion.
  • We expect to increase the size of our organization in certain jurisdictions and functions; as a result, we may encounter difficulties in managing our growth, which could disrupt our operations and/or increase our net losses.
  • In certain markets, we engage or anticipate engaging in direct sales efforts. We may fail to maintain and develop our direct sales force, and our revenues and financial outcomes could suffer as a result. Furthermore, our direct sales personnel may not effectively sell our products.
  • We may be subject to substantial warranty or product liability claims or other litigation in the ordinary course of business that may adversely affect our business, financial condition and operating results.
  • Counterfeit products may be represented as ours, which could compete with our genuine products and may also expose us to risks associated with adverse events and product liability.
  • Negative publicity concerning our products or our competitors’ products, including due to product defects or recalls and any resulting litigation, or long-term safety impacts, could harm our reputation and reduce demand for silicone breast implants, either of which could adversely impact our financial results and/or share price.
  • The loss of members of our executive management team or other employees, or other turnover in our management team, could adversely affect our business.
  • We have made multiple acquisitions in the past, and in the future, we may acquire other businesses, form joint ventures or make investments in other companies or technologies. If we are not successful in
  • integrating these businesses, as well as identifying and controlling risks associated with the past operations of these businesses, we may incur significant costs, receive penalties or other sanctions from various regulatory agencies and/or incur significant diversions of management time and attention.
  • We have significant exposure to the economic and political situations in emerging market countries, and developments in these countries could materially impact our financial results or our business more generally.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our liquidity and financial performance.
  • Our results of operations have been in the past, and could be in the future, adversely affected by fluctuations in currency rates.
  • Continued international expansion of our business will expose us to business, regulatory, political, operational, financial, economic and environmental risks associated with doing business internationally.
  • Environment, social and governance (ESG) matters may create additional risks and costs.
  • Any disruption at our existing facilities could adversely affect our business and operating results.
  • We may be required to record a significant charge to earnings if our goodwill or other intangible assets become impaired.
  • Fluctuations in insurance costs, availability and future insurance requirements could adversely affect our profitability or our risk management profile.
  • Risks Related to Manufacturing and Other Third-Party Relationships
  • Our operations involve hazardous materials and we and third parties with whom we contract must comply with environmental laws and regulations, which can be expensive and restrict how we do business and could expose us to liability if our use of such hazardous materials causes injury.
  • We rely on third parties to conduct certain components of our clinical studies, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such studies, which could interfere with or delay our ability to obtain regulatory approval or commercialize our products.
  • We rely on a single-source, third-party supplier for medical-grade long-term implantable silicone, which is the primary raw material used in our Motiva Implants. As has occurred in the past, if this supplier were to increase prices for this raw material or experience interruptions in its ability to supply us with this raw material, our business, financial condition and results of operations could be adversely affected.
  • Various factors outside our direct control, including the reliance on single-source suppliers, may adversely affect manufacturing and supply of our Motiva Implants and other products.
  • A substantial proportion of our sales are through exclusive distributors, and we do not have direct control over the efforts these distributors may use to sell our products. If our relationships with these third-party distributors deteriorate, or if these third-party distributors fail to sell our products or engage in activities that harm our reputation, or fail to adhere to medical device regulations, our financial results may be negatively affected.
  • Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory.
  • Risks Related to Public Health Crises
  • Pandemics, epidemics, or other public health crises may adversely affect our business and financial results in the future.
  • Risks Related to Intellectual Property and Data Security
  • If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, harming our business and competitive position.
  • If we are not able to obtain and maintain intellectual property protection for our products and technologies, or if the scope of our patents is not sufficiently broad, we may not be able to effectively maintain our market leading technology position.
  • The medical device industry is characterized by patent litigation, and we could become subject to litigation or other proceedings to protect or enforce our intellectual property rights that could be costly, result in the diversion of management’s time and efforts, require us to pay damages or prevent us from marketing our existing or future products.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If we fail to comply with our obligations in our intellectual property agreements, we could lose intellectual property rights that are important to our business.
  • Our information systems, or those used by third parties which we rely on, may fail, be impacted by cybersecurity incidents, suffer other security incidents or be vulnerable to other forms of attack or damage.
  • The use of artificial intelligence technology by our employees or business partners could result in misuse or loss of proprietary information, violation of laws and regulations, or damage to our reputation and credibility.
  • Our failure to adequately protect personal information in compliance with evolving legal requirements could harm our business.
  • Risks Related to Regulatory and Political Environment
  • The regulatory approval process is expensive, time consuming and uncertain. Our future success depends on our ability to develop, receive regulatory clearance or approval for, and introduce new products that will be accepted by the market in a timely manner. There is no guarantee that the FDA or similar foreign regulatory authority will authorize the commercialization of our planned products on a timely basis, if at all. Delays or failure to obtain necessary clearances or approvals would adversely affect our ability to grow our business.
  • Once commercialized, modifications to our marketed products may require new 510(k) clearances or approval of PMA supplements, or equivalent steps in other countries, or may require us to cease marketing or recall the modified products until certification, clearances or regulatory approvals are obtained.
  • Even if we receive regulatory approval for a planned product, we will be subject to ongoing regulatory obligations and continued regulatory review. Compliance with ongoing regulatory obligations and continued regulatory review may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.
  • Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of
  • serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
  • We are subject to extensive and dynamic medical device regulation, and oversight in the United States and other countries. If we fail to obtain or maintain necessary regulatory approvals for our products, or if approvals or clearances for future products are delayed or not issued, it will negatively affect our business, financial condition and results of operations.
  • Our products, such as Motiva Implants, may in the future be subject to product recalls that could harm our reputation, business and financial results.
  • The medical technology industry is complex and intensely regulated at the federal, state, and local levels, and government authorities may determine that we have failed to comply with applicable laws or regulations.
  • Our relationship with customers, patients and third party payors will be subject to applicable anti-kickback, fraud and abuse, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, damages, reputational harm and diminished profits and future earnings.
  • Healthcare reform measures could hinder or prevent our planned products’ commercial success.
  • The coverage and reimbursement status of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
  • Risks Related to Taxation
  • Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.
  • We are a multinational organization faced with increasingly complex tax issues in many jurisdictions, and changes in tax laws or their application to the operation of our business could adversely impact our operating results and our business.
  • Our ability to use net operating losses to offset future taxable income and certain other tax attributes may be subject to certain limitations.
  • U.S. holders of our common shares may suffer adverse tax consequences if we are characterized as a passive foreign investment company.
  • If a United States person is treated as owning at least 10% of our common shares, such holder may be subject to adverse U.S. federal income tax consequences.
  • Discontinuation of preferential tax treatments we currently enjoy or other unfavorable changes in tax law could result in additional compliance obligations and costs.
  • Risks Related to Ownership of Our Securities
  • Our share price may be volatile, and purchasers of our securities could incur substantial losses.
  • We identified a material weakness in our internal control over financial reporting as of December 31, 2023, and 2022, and may identify additional material weaknesses in the future that may cause us to fail to meet our reporting obligations or result in material misstatements of our consolidated financial statements. If we fail to establish and maintain effective control over financial reporting, our ability to accurately and timely report our financial results could be adversely affected.
  • Risks Related to Being a British Virgin Islands Company
  • Rights of shareholders under British Virgin Islands law differ from those under U.S. law, and, accordingly, you may have fewer protections as a shareholder.
  • British Virgin Islands companies may not be able to initiate shareholder derivative actions, thereby depriving shareholders of one avenue to protect their interests.
  • British Virgin Islands law differs from the laws in effect in the United States, and U.S. investors may have difficulty enforcing civil liabilities against us, our directors or members of senior management.
  • The laws of the British Virgin Islands provide limited protection for minority shareholders, so minority shareholders will have limited or no recourse if they are dissatisfied with the conduct of our affairs.
  • Provisions in our amended and restated memorandum and articles of association and under British Virgin Islands law could make an acquisition of us more difficult and may prevent attempts by our shareholders to replace or remove our current management.

Legal proceedings

We are and may become from time to time a party to various claims and lawsuits arising in the ordinary course of business, but we are not a party to any material legal proceeding required to be disclosed under Item 103 of Regulation S-K.

The opening of Item 3, Legal Proceedings.5

Sources

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