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Tue Oct 27 · markets open3 signals today140 insider buys this week · $73.9MCIRO short report next: Oct 31The week ahead

ESTA

ESTABLISHMENT LABS HOLDINGS INC.
NASDAQ · HEALTH CARE · ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES
66.36
+0.58 +0.89%
USD · close Oct 27
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Work order
33
FLAG · shorts 33
Insiders, 90 days
0
no open-market filings in 90 days
Congress, 90 days
0 / 0
no disclosures naming it
Big money
0 / 15
none of the tracked funds disclose it
Calls on record
0
nobody we score has called it yet
MKT CAP $2BP/E —DIV YIELD —FCF YIELD -2.10%REV TTM $245.8M +38.6%NET INCOME −$38.9MNET CASH $71.2M52W 47.80 – 95.65SEC XBRL · TTM TO Invalid Date

How ESTA rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
72%
of sentences unchanged
Added
146
new sentences
Dropped
109
sentences removed
Length
+1,200
words, now 27,176

New in FY2025

  • We marketed our products solely in countries outside of the United States from October 2010 until 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander in October 2023 and FDA approval of our Motiva Implants in September 2024, and as such, we have a limited operating history in the United States upon which to evaluate our business and forecast our future net sales and operating results.
  • In addition, we may fail to identify or respond effectively to emerging trends that could negatively affect our business.
  • Furthermore, in most countries, we need to obtain regulatory approval in order to market and sell our products, which may limit our ability to act quickly in scaling commercialization in those countries.
  • The Trump Administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities, such as implementing statutes through rulemaking, issuance of guidance, and review and approval of applications.
  • Additionally, the FDA is transitioning from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR), with the transition period concluding in February 2026.
  • This transition requires us to align our quality management systems with the new requirements, which may require significant resources and operational adjustments.
  • Failure to comply with QMSR requirements by the applicable deadline could result in enforcement actions, delays in product approvals, or other adverse regulatory consequences.
  • Disruptions at the FDA and other agencies, including staffing reductions, funding limitations, or policy changes under the current or future administrations, may also slow the time necessary for new drugs and devices to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.
  • Any reduction in FDA resources or changes in regulatory priorities could delay approval of our products or modifications to existing products, extend the timeline for compliance activities, or otherwise adversely affect our business.
  • A prolonged government shutdown occurs, or other events, including uncertainty regarding the FDA’s funding, operations or policy goals, that prevents the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities in a timely manner could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
  • As part of our effort to educate and train plastic surgeons through our medical educational platform, we completed 607 and 239 medical training sessions worldwide during 2025 and 2024, respectively.
  • 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.
  • Manufacturing silicone breast implants requires costly capital equipment and a highly skilled workforce.
  • 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.
  • Sales of our Motiva Implants accounted for approximately 99% and 96% of our revenues for each of the years ended December 31, 2025 and 2024, respectively, and we expect our revenues to continue to be driven primarily by sales of these products.
  • We do not expect to be profitable in 2026, and in future years we expect to incur significant research and development expenses related to, among other things, the IDE and the post-approval clinical studies of Motiva Implants in the United States.
  • As of December 31, 2025, we had an accumulated deficit of $495.8 million.
  • If we are unable to continue to commercialize Motiva Implants and our other products, or if we are unable to obtain a partner to commercialize them, we may not be able to produce any incremental revenues related to Motiva Implants and our other products.
  • Our results of operations have been in the past, and could be in the future, adversely affected by general conditions in the global economy and in the global financial markets, such as trade wars, slower growth or recession, adverse impacts on currency exchange rates, continued inflation or decreases in consumer spending or confidence, as well as changing political conditions.
  • Elective aesthetic procedures, including breast augmentation, are typically not covered by insurance and are less of a priority than other items for patients that have lost their jobs, are furloughed, have reduced work hours or have to allocate their cash to other priorities.
  • As a result, adverse changes in the global economy, including as a result of inflationary pressures, elevated interest rates, geopolitical conflicts, including the Russia-Ukraine war and the Hamas-Israel conflict, political instability or macroeconomic fallout from significant U.S. policy changes and government spending cuts, may cause consumers to reassess their spending choices and reduce demand for elective aesthetic procedures, as well as may disrupt global supply chains, increase costs for raw materials and logistics, and create broader macroeconomic instability, which could have an adverse effect on our net sales and profitability.
  • In addition, the growing availability and adoption of glucagon-like peptide-1 (GLP-1) drugs and related pharmaceutical therapies for obesity and metabolic conditions could reduce discretionary consumer spending on elective aesthetic procedures and/or reduce underlying demand for certain procedures if these therapies directly or indirectly address patient concerns that might otherwise by treated with our products.
  • The Trump Administration has imposed additional tariffs on imports from various countries as well as imposed baseline reciprocal tariffs on imports from certain trading partners.
  • These tariffs, and any additional tariffs that may be imposed, could increase our costs for raw materials, components, and finished goods and may adversely affect our supply chain and manufacturing operations in Costa Rica.
  • In response to U.S. trade actions, certain countries have imposed or threatened to impose retaliatory actions against the United States, including retaliatory tariffs on U.S. goods, which could affect demand for our products in those markets or otherwise disrupt global trade.
  • The ultimate impact of tariffs will depend on various factors, including the scope, timing, amount, nature, implementation, and duration of such tariffs, as well as any retaliatory measures by other countries, but could materially increase our operating costs, reduce demand for our products, and adversely affect our financial condition and results of operations.
  • These policies may also lead to supply chain constraints and additional inflation, further increasing operational costs and may result in reductions in discretionary spending in our markets and demand for our products.
  • If we raise additional funds through collaborations or partnerships, or marketing, distribution or licensing arrangements with third parties, we may be required to do so at an earlier stage than would otherwise be ideal and/or may have to limit valuable rights to our intellectual property, technologies, products, or future revenue streams, or grant licenses or other rights on terms that are not favorable to us.
  • We utilize social media and may engage high-profile influencers to increase brand awareness and educate consumers, which increases the risk that promotional content is alleged to be false, misleading, or otherwise non-compliant with FDA and other advertising and promotion requirements.
  • Even with contractual controls and monitoring, influencer content may deviate from our guidelines or include off-label or otherwise problematic claims, creating heightened compliance and enforcement risk due to the speed and reach of social platforms.
  • (acquired by Tiger Aesthetics Medical), Mentor Worldwide LLC (a division of Johnson & Johnson) and Allergan plc (acquired by AbbVie Inc.) have conducted large prospective clinical studies that started in the United States in 2002, 2000 and 1998, respectively, and they use this data extensively to promote their products.
  • This can put us at a disadvantage when promoting our products to physicians and patients, even outside of the United States.
  • As of December 31, 2025, we had 1,004 employees.
  • We have established a direct sales force for our business in Brazil and the United States, and we have implemented a direct sales strategy in several European countries.
  • We face an inherent risk of product liability exposure related to the sale of Motiva Implants and our other products.
  • 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.
  • News coverage in recent years has called into question the long-term safety of breast implants, including through reports of breast implant-associated anaplastic large cell lymphoma linked to our competitors’ products which have led to regulatory actions regarding macrotextured devices in several countries and the worldwide recall of one of our competitor’s macrotextured implants and tissue expanders.
  • In the fourth quarter of 2018, following the non-renewal of its textured breast implant CE Certificates of Conformity in Europe, Allergan plc suspended sales of textured breast implants in Europe and withdrew its remaining textured breast implants on the market within Europe.
  • In October 2021, the FDA took several additional actions to strengthen breast implant risk communication, including restricting the sale and distribution of breast implants to only healthcare providers and facilities that provide information to patients using the patient decision checklist.
  • The FDA noted that, while the agency believes the occurrences of SCC or various lymphomas in the capsule around the breast implant to be rare, healthcare providers and people who have or are considering breast implants should be aware that cases have been reported to the FDA and in the literature.

and 106 more.

Gone since FY2024

  • Our products were marketed solely in countries outside of the United States from October 2010 until 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander in October 2023 and FDA approval of our Motiva Implants in September 2024, and as such, we have a limited operating history in the United States upon which to evaluate our business and forecast our future net sales and operating results.
  • In addition, we may not be able to develop insights into trends that could emerge and negatively affect our business and may fail to respond effectively to those trends.
  • Furthermore, in most countries, we need to obtain regulatory approval in order to market and sell our products, which may limit our ability to act quickly in scaling commercialization in those countries, including the United States.
  • The new Trump Administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities, such as implementing statutes through rulemaking, issuance of guidance, and review and approval of applications.
  • Disruptions at the FDA and other agencies may also slow the time necessary for new drugs and devices to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.
  • If a prolonged government shutdown occurs, or if other events, including uncertainty regarding the FDA’s funding, operations or policy goals, prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities in a timely manner, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
  • As part of our effort to educate and train plastic surgeons through our medical educational platform, we completed 239 and 192 medical training sessions worldwide during 2024 and 2023, respectively.
  • Commercial success of Motiva Implants in the United States or elsewhere depends on our ability to accurately forecast customer demand and manufacture sufficient quantities of product in the implant sizes that patients and physicians request, and to 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.
  • Manufacturing of silicone breast implants requires costly capital equipment and a highly skilled workforce.
  • Until 2017, we had one manufacturing facility in Costa Rica, causing occasional inventory shortages.
  • In March 2017, our second Costa Rica facility became operational, received MDSAP certification, and began shipping products.
  • Construction of a third facility started in 2021 and was completed in 2024.
  • In August 2024, the smallest facility was shut down.
  • Risks Related to Our Business, Industry and Operations We expect to incur losses for the foreseeable future, and our ability to achieve and maintain profitability depends on the commercial success of our Motiva Implants.
  • Sales of our Motiva Implants accounted for approximately 96% and 95% of our revenues for each of the years ended December 31, 2024 and 2023, respectively, and we expect our revenues to continue to be driven primarily by sales of these products.
  • We do not expect to be profitable in 2025, and in future years we expect to incur significant research and development expenses related to, among other things, the IDE clinical study of Motiva Implants in the United States.
  • As of December 31, 2024, we had an accumulated deficit of $444.7 million.
  • If we are unable to continue to commercialize Motiva Implants and our other products, or unable to obtain a partner to commercialize them, we may not be able to produce any incremental revenues related to Motiva Implants and our other products.
  • Our results of operations have been in the past, and could be in the future, adversely affected by general conditions in the global economy and in the global financial markets, such as slower growth or recession, adverse impacts on currency exchange rates, continued inflation or decreases in consumer spending or confidence, as well as changing political conditions.
  • Elective aesthetic procedures, including breast augmentation, are typically not covered by insurance and are less of a priority than other items for those patients that have lost their jobs, are furloughed, have reduced work hours or have to allocate their cash to other priorities.
  • As a result, adverse changes in the global economy, including as a result of inflationary pressures, elevated interest rates, geopolitical conflicts, including the Russia-Ukraine war and the Hamas-Israel conflict, political instability or macroeconomic fallout from significant U.S. government spending cuts, may cause consumers to reassess their spending choices and reduce demand for elective aesthetic procedures, which could have an adverse effect on our net sales and profitability.
  • The Trump administration has imposed additional tariffs on imported products and indicated it will continue to do so.
  • The ultimate impact of tariffs will depend on various factors, including the scope, timing, amount, nature and implementation, but tariffs would likely have a negative impact on the global macroeconomy and on our business.
  • In response to U.S. trade actions, certain countries may impose retaliatory actions against the U.S.
  • These policies may lead to supply chain constraints and additional inflation, further increasing operational costs.
  • If we raise additional funds through collaborations, strategic collaborations or partnership, or marketing, distribution or licensing arrangements with third parties, we may be required to do so at an earlier stage than would otherwise be ideal and/or may have to limit valuable rights to our intellectual property, technologies, products, or future revenue streams, or grant licenses or other rights on terms that are not favorable to us.
  • (recently acquired by Tiger Aesthetics Medical), Mentor Worldwide LLC (a division of Johnson & Johnson) and Allergan plc ( acquired by AbbVie Inc.) have conducted large prospective clinical studies that started in the United States in 2002, 2000 and 1998, respectively, and they use this data extensively to promote their products.
  • This can put us at a disadvantage when promoting our products to physicians and patients, even outside the United States.
  • As of December 31, 2024, we had 1,018 employees.
  • We have established a direct sales force for our business in Brazil and United States, and we have implemented a direct sales strategy in several European countries.
  • We face an inherent risk of product liability exposure related to the sale of Motiva Implants and our other products in clinical studies.
  • Negative publicity concerning our products or our competitors’ products, including due to product defects, 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.
  • News coverage in recent years has called into question the long-term safety of breast implants and reports of breast implant-associated anaplastic large cell lymphoma linked to our competitors’ products which have led to regulatory actions regarding macrotextured devices in several countries and the worldwide recall of one of our competitor’s macrotextured implants and tissue expanders.
  • In the fourth quarter of 2018, following the non-renewal of its textured breast implant CE Mark licenses in Europe, Allergan plc suspended sales of textured breast implants in Europe and withdrew its remaining textured breast implants on the market within Europe.
  • In October 2021, the FDA took several additional actions to strengthen breast implant risk communication, including restricting the sale and distribution of breast implants to only health care providers and facilities that provide information to patients using the patient decision checklist.
  • The FDA noted that, while the agency believes the occurrences of SCC or various lymphomas in the capsule around the breast implant to be rare, health care providers and people who have or are considering breast implants should be aware that cases have been reported to the FDA and in the literature.
  • To date, no cases of BIA-ALCL or SCC have been reported in patients with Motiva Implants.
  • Future clinical studies or clinical experience may indicate that breast implants expose potentially genetically predisposed patients to greater risks of BIA-ALCL, which may reduce demand for silicone implants generally, expose us to product liability claims, as well as to class actions and other lawsuits.
  • These impacts may occur in the absence of any specific linkage with our products.
  • Our success in implementing our business strategy depends largely on the skills, experience and performance of members of our executive management team and other key employees, including Juan José Chacón Quirós, our Chief Executive Officer who is set to retire in March 2025, Peter Caldini, our President and upcoming Interim Chief Executive Officer, Roberto de Mezerville, our Chief Technology Officer, Rajbir Denhoy, our Chief Financial Officer, and Ross Mansbach, our General Counsel and Chief Human Resources Officer.

and 69 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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