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ESTABLISHMENT LABS HOLDINGS INC.

ESTA
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Business Summary

Establishment Labs Holdings Inc. is a global medical technology company primarily focused on improving patient safety and aesthetic outcomes within the breast aesthetics and reconstruction market. The company's core business revolves around its line of silicone gel-filled breast implants, branded as Motiva Implants, which have been the primary driver of revenue since their commercial launch in October 2010. The company generates revenue through sales to medical device distributors and direct sales to physicians, hospitals, and clinics, with revenue recognized at shipment or upon notification of implantation for consigned inventory. The majority of the company's manufacturing activities are conducted in ISO-13485-certified facilities in Costa Rica, which also benefit from tax-advantaged status.

The company's competitive positioning is based on its Motiva Implants, which are differentiated by proprietary technologies designed to improve safety and aesthetic outcomes. These include SmoothSilk/SilkSurface for reduced capsular contracture, Qid RFID technology (and its latest generation, ZEN) for product identification and traceability, BluSeal visual barrier layer for manufacturing quality control, and TrueMonobloc gel-shell-patch configuration for durability and smaller incisions. The company highlights its 5-year results from its Motiva U.S. IDE study and 15-year post-market surveillance data, which indicate low rates of adverse events such as rupture, capsular contracture, and implant-related reoperations, comparing favorably to competitors.

Establishment Labs' product portfolio includes five families of Motiva Implants: Round and Ergonomix Round, Ergonomix Oval, Anatomical TrueFixation, Ergonomix2 Round and Ergonomix2 Diamond, and the Flora Tissue Expander. Motiva Implants are Class III Medical Devices indicated for breast augmentation and reconstruction, including revision surgeries. The Ergonomix design offers a gravity-sensitive, natural appearance, while the ProgressiveGel platform provides viscoelastic properties mimicking natural breast tissue. The company's catalog offers over 1,000 product variations in different shapes and volumes.

The Motiva Flora Tissue Expander is a temporary implant used in breast reconstruction, featuring the SmoothSilk surface and an integrated RFID port with no magnets, making it MRI Conditional. It received CE mark in June 2020 and 510(k) clearance from the FDA in October 2023. The company's minimally invasive aesthetics offerings include Preservé, launched in February 2025, a breast tissue-preserving technology for augmentation, revision, and mastopexy augmentation, initially launched in Brazil with further launches planned for 2025 and a full U.S. launch in 2026. Mia Femtech, launched in April 2023, is a patient-centric procedure for breast augmentation under local anesthesia, utilizing the Ergonomix2 Diamond implant and proprietary tools, with a 3-year reoperation rate of 1%.

For the fiscal year ended December 31, 2025, Establishment Labs reported total revenue of $211.076 million , an increase of 27.2% from $166.025 million in 2024. Gross profit for 2025 was $146.308 million , resulting in a gross margin of 69.3% , up from 66.0% in 2024. Operating expenses totaled $185.316 million , leading to a loss from operations of $(39.008) million . Net loss for the year was $(51.064) million , compared to $(84.596) million in 2024. Diluted EPS was $(1.72) . The company reported cash and cash equivalents of $75.572 million as of December 31, 2025, and total debt (Note payable, Oaktree, net of debt discount and issuance costs) of $247.522 million . Free cash flow is not explicitly stated, but net cash used in operating activities was $(50.890) million .

Year-over-year, revenue increased by $45.1 million , or 27.2% . Gross margin expanded by 3.3 percentage points to 69.3% , primarily driven by higher selling prices in the United States. Sales, general and administrative (SG&A) expenses increased by $25.3 million , or 18.1% , to $165.069 million . Research and development (R&D) expenses saw a modest increase of $0.5 million , or 2.5% , reaching $20.247 million . Interest expense rose by $4.4 million , or 21.6% , to $25.256 million . Other income (expense), net, improved significantly, moving from an expense of $(13.812) million in 2024 to an income of $6.242 million in 2025, largely due to the absence of $6.0 million in contract termination costs from 2024 and a foreign currency transaction gain of $6.4 million . North America revenue increased significantly to $45.557 million in 2025 from $4.410 million in 2024, while Asia-Pacific revenue decreased by 28.6% to $34.541 million .

During 2025, Establishment Labs made several operational and strategic moves. Peter Caldini was appointed CEO on May 7, 2025, following the retirement of Juan José Chacón-Quirós. The company partnered with GRAMMY winner Meghan Trainor in March 2025 for its U.S. market launch, generating over 9 billion media impressions. In February 2025, Preservé, a minimally invasive breast tissue-preserving technology, was launched in Brazil, with further launches planned for other countries in 2025 and a full U.S. launch in 2026. The 3-year results of the Mia Femtech clinical study were published in October 2025, showing a 1% reoperation rate and no reports of capsular contracture (Baker Grade III/IV), implant rupture, or BIA-ALCL. The company also secured over 1,500 accounts in the United States by December 31, 2025, for Motiva Implants. In terms of manufacturing, the U.S. FDA authorized the Costa Rican facilities to manufacture all Motiva USA PMA-approved products in 2025, expanding U.S.-bound production capacity.

Business Outlook

Management anticipates continued growth in existing markets, driven by Motiva Implants and the expanding portfolio of minimally invasive products, including Preservé and Mia Femtech. The company expects overall operating expenses to increase compared to 2025 due to commercial and operational activities following FDA approval of Motiva Implants, though management remains focused on managing these expenses. The company does not expect to be profitable in 2026.

A major growth area is the expansion of revenues in the U.S. market, following the FDA PMA approval for Motiva Implants in September 2024 and 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander in October 2023. The U.S. is identified as one of the largest breast implant markets globally, and Motiva Implants are the first new breast implant PMA-approved by the FDA since 2013. The company has already secured over 1,500 accounts across the United States by December 31, 2025, and generated $45.6 million in U.S. sales for the year ended December 31, 2025. This expansion is supported by a multi-faceted marketing strategy including social media, influencers, conferences, online advertising, and patient and physician education programs.

Another significant growth vector is the expansion of the minimally invasive product portfolio. Preservé, a breast tissue-preserving technology, was launched in Brazil in February 2025, with further launches in other countries throughout 2025, including an early experience group in the United States. A full launch in the United States is expected in 2026. Mia Femtech, a procedure for breast augmentation under local anesthesia, is currently offered in multiple countries, with management believing it will attract new consumers and expand the market. The 3-year clinical study results for Mia Femtech, published in October 2025, showed a very low complication rate and high patient and surgeon satisfaction, with an 87% increase in breast satisfaction at 3 years and 90% of surgeons "very satisfied."

Operationally, the company expects R&D expenses to remain elevated for the foreseeable future as it continues to advance products under development and prepare for additional clinical studies. The IDE clinical trial for Motiva Implants in the United States is expected to cost between $30.0 million and $40.0 million over ten years, with approximately $33.5 million spent to date as of December 31, 2025. A post-approval study (PAS) is also required, estimated to incur between $4.0 million to $5.0 million over the next 10 years, enrolling 2,400 patients across three cohorts at up to 50 study sites in the United States. Patient participation for the PAS began in April 2025, with first surgeries in May 2025.

The company's manufacturing capacity has been significantly expanded with the completion of the Suláyöm Innovation Campus in June 2024, adding approximately 730,000 units per year to manufacturing capacity, with space for further expansion. This facility obtained necessary regulatory approvals and commenced manufacturing by the end of fiscal 2024. Both Costa Rican facilities are Carbon Neutral certified and have received MDSAP regulatory certification. In 2025, the U.S. FDA authorized these facilities to manufacture all Motiva USA PMA-approved products, supporting long-term operational efficiency.

Planned capital allocation includes continued significant R&D spending. The company's liquidity requirements for at least the next 12 months are expected to be met by available cash and cash from operations. Long-term liquidity needs include operating expenses, increased SG&A and R&D expenses related to clinical trials, regulatory compliance, product development, and principal and interest payments on term loans. The company has an Inventory Funding Agreement to finance up to $10 million in silicone raw material purchases at a 12% annual interest rate, with $10 million drawn in 2025. Short-term insurance premium financing arrangements totaled approximately $3.4 million at interest rates from 7.7% to 8.3% . The company also drew $25 million from the Tranche D Term Loan in September 2025.

Management explicitly flagged several structural headwinds and execution risks. The current global macroeconomic environment is complex, with escalating trade tensions, tariff uncertainty, capital market volatility, fluctuating exchange rates, declining consumer sentiment, and elevated inflation and interest rates, which could reduce discretionary spending on elective aesthetic procedures. The growing availability and adoption of GLP-1 drugs for obesity and metabolic conditions could also reduce discretionary consumer spending on elective aesthetic procedures or underlying demand for certain procedures. The company also faces potential supply chain disruptions and increased costs for raw materials and logistics due to these macroeconomic factors.

Geographically, the company has significant exposure to emerging market countries, with economic and political developments in Brazil and other emerging markets potentially having an adverse effect on financial results. While demand in EMEA and Latin America improved in 2025, Asia-Pacific revenue decreased, primarily due to a China distributor selling through inventory and lower consumer demand for aesthetic procedures. The company's reliance on Avantor as a single-source supplier for medical-grade long-term implantable silicone poses a risk, as Avantor has indicated it does not intend to automatically renew the supply agreement and plans to negotiate future terms.

Risk Factors

The company faces material risks from unfavorable global economic and political conditions, including slower growth or recession, inflation, decreased consumer spending, and trade wars, which could reduce demand for elective aesthetic procedures and disrupt supply chains. The growing availability of GLP-1 drugs for obesity could also reduce discretionary spending on aesthetic procedures. Operational risks include the reliance on a single-source supplier, Avantor, for medical-grade silicone, which constitutes 55.8% of total purchases in 2025, and Avantor's recent notification that it does not intend to automatically renew the supply agreement, potentially leading to supply interruptions or price increases. The company is exposed to product liability claims, negative publicity, and potential reductions in demand for silicone breast implants due to safety concerns, including reports of BIA-ALCL and SCC linked to competitors' products, although no cases have been reported for Motiva Implants. Cybersecurity threats and other security incidents to information systems, or those of third parties, could lead to operational disruptions, loss of proprietary information, and reputational harm. The regulatory approval process is expensive, time-consuming, and uncertain, with potential delays or failures to obtain necessary clearances or approvals, and ongoing compliance with regulations like the EU MDR and the FDA's QMSR, which transitions fully in February 2026, could result in significant additional expenses or penalties.

Management Priorities

Management's message emphasizes a commitment to improving patient safety and aesthetic outcomes through product innovation, with a particular focus on the Motiva Implants platform. They highlight the favorable safety profile of Motiva Implants, citing low adverse event rates from clinical studies and post-market surveillance data. A key strategic priority is the expansion of revenues in the U.S. market, following FDA PMA approval in September 2024, where Motiva Implants generated $45.6 million in sales in 2025 and the company secured over 1,500 accounts . Another priority is the continued growth in existing international markets and the expansion of the minimally invasive product portfolio, including the recent launch of Preservé in Brazil in February 2025 and the global rollout of Mia Femtech. Management acknowledges the complex global macroeconomic environment, including trade tensions, inflation, and interest rate volatility, which could impact discretionary spending on aesthetic procedures, and notes that they do not expect to be profitable in 2026. They also emphasize ongoing investment in R&D, with an estimated $4.0 million to $5.0 million to be incurred for the post-approval study over the next 10 years, and a focus on managing operating expenses despite expected increases.

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 1, Business — Overview; Our Products and Technologies
  3. [3] Item 1, Business — Our Products and Technologies
  4. [4] Item 1, Business — Our Products and Technologies; Recent Developments Regulatory and Operational Updates
  5. [5] Item 7, MD&A — Consolidated Results of Operations
  6. [6] Item 7, MD&A — Financial Highlights
  7. [7] Item 7, MD&A — Consolidated Results of Operations
  8. [8] Item 7, MD&A — Consolidated Results of Operations
  9. [9] Item 7, MD&A — Comparison of the Year Ended December 31, 2025 and 2024
  10. [10] Item 7, MD&A — Comparison of the Year Ended December 31, 2025 and 2024
  11. [11] Item 7, MD&A — Consolidated Results of Operations
  12. [12] Item 7, MD&A — Consolidated Results of Operations
  13. [13] Item 7, MD&A — Consolidated Results of Operations
  14. [14] Item 7, MD&A — Consolidated Results of Operations
  15. [15] Item 7, MD&A — Consolidated Statements of Operations
  16. [16] Item 7, MD&A — Financial Highlights
  17. [17] Item 7, MD&A — Material Cash Requirements
  18. [18] Item 7, MD&A — Net Cash Used in Operating Activities
  19. [19] Item 7, MD&A — Comparison of the Year Ended December 31, 2025 and 2024
  20. [20] Item 7, MD&A — Comparison of the Year Ended December 31, 2025 and 2024
  21. [21] Item 7, MD&A — Comparison of the Year Ended December 31, 2025 and 2024
  22. [22] Item 7, MD&A — Comparison of the Year Ended December 31, 2025 and 2024
  23. [23] Item 7, MD&A — Operating Expenses
  24. [24] Item 7, MD&A — Operating Expenses
  25. [25] Item 7, MD&A — Operating Expenses
  26. [26] Item 7, MD&A — Operating Expenses
  27. [27] Item 7, MD&A — Operating Expenses
  28. [28] Item 7, MD&A — Operating Expenses
  29. [29] Item 7, MD&A — Interest Expense
  30. [30] Item 7, MD&A — Interest Expense
  31. [31] Item 7, MD&A — Interest Expense
  32. [32] Item 7, MD&A — Other Income (Expense), Net
  33. [33] Item 7, MD&A — Other Income (Expense), Net
  34. [34] Item 7, MD&A — Other Income (Expense), Net
  35. [35] Item 7, MD&A — Other Income (Expense), Net
  36. [36] Item 2, Note 2 — Revenue Recognition
  37. [37] Item 2, Note 2 — Revenue Recognition
  38. [38] Item 7, MD&A — Comparison of the Year Ended December 31, 2025 and 2024
  39. [39] Item 2, Note 2 — Revenue Recognition
  40. [40] Item 1, Business — Recent Developments Regulatory and Operational Updates; Our Clinical Data; Manufacturing and Suppliers; Item 7, MD&A — Business Update Regarding Macroeconomic Conditions
  41. [41] Item 7, MD&A — Business Update Regarding Macroeconomic Conditions; Risks Related to Our Business, Industry and Operations
  42. [42] Item 7, MD&A — Business Update Regarding Macroeconomic Conditions
  43. [43] Item 1, Business — Our Growth Strategy; Sales and Marketing; Item 7, MD&A — Business Update Regarding Macroeconomic Conditions
  44. [44] Item 1, Business — Recent Developments Regulatory and Operational Updates
  45. [45] Item 1, Business — Recent Developments Regulatory and Operational Updates
  46. [46] Item 1, Business — Our Growth Strategy; Minimally Invasive Aesthetics: Preservé and Mia Femtech; Our Clinical Data
  47. [47] Item 7, MD&A — Research and Development
  48. [48] Item 7, MD&A — Research and Development
  49. [49] Item 7, MD&A — Research and Development
  50. [50] Item 7, MD&A — Research and Development
  51. [51] Item 7, MD&A — Research and Development
  52. [52] Item 7, MD&A — Research and Development
  53. [53] Item 7, MD&A — Research and Development
  54. [54] Item 7, MD&A — Research and Development
  55. [55] Item 1, Business — Manufacturing and Suppliers
  56. [56] Item 1, Business — Manufacturing and Suppliers
  57. [57] Item 7, MD&A — Financing Activities
  58. [58] Item 7, MD&A — Financing Activities
  59. [59] Item 7, MD&A — Financing Activities
  60. [60] Item 7, MD&A — Financing Activities
  61. [61] Item 7, MD&A — Financing Activities
  62. [62] Item 7, MD&A — Financing Activities
  63. [63] Item 7, MD&A — Financing Activities
  64. [64] Item 7, MD&A — Liquidity and Capital Resources
  65. [65] Item 7, MD&A — Business Update Regarding Macroeconomic Conditions; Item 1A, Risk Factors — Unfavorable global economic and political conditions
  66. [66] Item 7, MD&A — Business Update Regarding Macroeconomic Conditions; Item 1A, Risk Factors — We rely on a single-source, third-party supplier
  67. [67] Item 2, Note 2 — Concentration of Credit Risk and Other Risks and Uncertainties
  68. [68] Item 1A, Risk Factors — Summary of Risk Factors; Risks Related to the Development and Commercialization of Our Products; Risks Related to Our Business, Industry and Operations; Risks Related to Manufacturing and Other Third-Party Relationships; Risks Related to Intellectual Property and Data Security; Risks Related to Regulatory and Political Environment
  69. [69] Item 7, MD&A — Business Update Regarding Macroeconomic Conditions
  70. [70] Item 7, MD&A — Business Update Regarding Macroeconomic Conditions
  71. [71] Item 7, MD&A — Research and Development
  72. [72] Item 7, MD&A — Research and Development
  73. [73] Item 7, MD&A — Business Update Regarding Macroeconomic Conditions; Item 7, MD&A — Research and Development

Analysis on 5/21/2026