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ESTABLISHMENT LABS HOLDINGS (ESTA)

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Earnings summaries and quarterly performance for ESTABLISHMENT LABS HOLDINGS.

Recent press releases and 8-K filings for ESTA.

Establishment Labs Reports Strong 2025 Performance and Outlines 2026 Growth Strategy
ESTA
Guidance Update
Revenue Acceleration/Inflection
Product Launch
  • Establishment Labs reported a successful 2025, with pre-announced global revenue growth of 27% to between $210.5 million and $211.5 million, and achieved EBITDA positive in Q3 2025.
  • The U.S. market launch was strong, generating over $45 million in revenue in its first year (2025) and securing an estimated market share of approximately 20% by year-end.
  • The company projects a minimum of 25% growth in 2026 and 2027, driven by the minimally invasive Preservae platform (expected to contribute over $30 million in 2026), expansion into smaller implant sizes, and the upcoming Recon indication, which could double the addressable market.
  • Profitability is a key focus, with gross profit margins now above 70% and the company anticipating becoming free cash flow positive in 2026.
1 day ago
Establishment Labs Reports Strong 2025 Performance and Positive 2026 Outlook
ESTA
Guidance Update
Revenue Acceleration/Inflection
Product Launch
  • Establishment Labs (ESTA) reported 27% global growth in 2025, with revenue between $210.5 million and $211.5 million, and achieved over $45 million in U.S. revenue in its first year post-FDA approval.
  • The company became EBITDA positive in Q3 2025 and expects to maintain this into Q4 2025, with a cash balance of $75.5 million at the end of 2025.
  • ESTA anticipates at least 25% growth over the next two years (2026 and 2027) and expects to be cash flow positive in 2026.
  • Key growth drivers for 2026 include the formal U.S. launch of the minimally invasive Preservae platform, projected to generate over $30 million in revenue, and the expansion of the U.S. sales force by up to 15 representatives.
  • The company also achieved a gross margin above 70% in 2025, driven by higher-margin opportunities in the U.S. and direct markets.
1 day ago
Establishment Labs Reports Strong 2025 Performance and Outlines Growth Strategy
ESTA
Earnings
Guidance Update
Product Launch
  • Establishment Labs reported 27% global revenue growth for 2025, with total revenue between $210.5 million and $211.5 million. The U.S. market, launched in 2025, generated over $45 million in its first year, achieving approximately 20% market share by the end of 2025.
  • The company achieved EBITDA positive in Q3 2025 and expects to maintain this in Q4 2025, with its cash balance improving to $75.5 million by the end of 2025. Gross margin surpassed 70% in 2025, with expectations for continued significant margin expansion in the coming years.
  • Management anticipates at least 25% revenue growth over the next two years (2026 and 2027) and is on track to be cash flow positive in 2026.
  • Key growth drivers include the minimally invasive Preservé platform, projected to contribute over $30 million in revenue in 2026 , and the upcoming recon indication approval, which is expected to double the addressable U.S. market with a real commercial impact in 2027.
1 day ago
Establishment Labs Announces Preliminary Q4 and FY 2025 Financial Results
ESTA
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Establishment Labs Holdings Inc. expects preliminary unaudited revenue for Q4 2025 to be between $64.0 million and $65.0 million.
  • For fiscal year 2025, total revenue is anticipated to range from $210.5 million to $211.5 million, representing approximately 27% growth over 2024.
  • The company's year-end 2025 cash position is expected to be approximately $75.5 million, an increase of $4.8 million from the end of the third quarter of 2025.
  • CEO Peter Caldini highlighted record quarterly revenue and expects the company to become free cash flow positive later in 2026.
3 days ago
Establishment Labs Announces Preliminary Unaudited Financial Results for Q4 and FY 2025
ESTA
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Establishment Labs' preliminary unaudited revenue for Q4 2025 is expected to be between $64.0 million and $65.0 million, including $17.0 million to $17.5 million from Motiva sales in the United States.
  • Preliminary unaudited revenue for fiscal year 2025 is expected to be in the range of $210.5 million to $211.5 million, representing approximately 27% growth over 2024.
  • The company's year-end 2025 cash position is expected to be approximately $75.5 million, an increase of $4.8 million from the end of the third quarter of 2025.
  • Management anticipates turning free cash flow positive later in 2026 and expects operating leverage to become evident in 2026 and beyond.
3 days ago
Establishment Labs Submits Motiva Implants for FDA Approval in Breast Reconstruction
ESTA
Product Launch
New Projects/Investments
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA) has submitted Motiva® implants for approval in primary and revision breast reconstruction to the U.S. Food and Drug Administration (FDA).
  • The Motiva® implants were previously approved by the FDA for use in breast augmentation on September 27, 2024.
Dec 29, 2025, 1:15 PM
Establishment Labs Submits Motiva Implants for FDA Approval in Breast Reconstruction
ESTA
Product Launch
New Projects/Investments
  • Establishment Labs Holdings Inc. submitted Motiva® implants for approval in primary and revision breast reconstruction to the U.S. Food and Drug Administration (FDA) on December 29, 2025.
  • The Motiva® implants were previously approved by the FDA for use in breast augmentation on September 27, 2024.
Dec 29, 2025, 1:12 PM
Establishment Labs Submits Motiva Implants for FDA Approval in Breast Reconstruction
ESTA
Product Launch
New Projects/Investments
  • Establishment Labs Holdings Inc. has submitted its Motiva implants for FDA approval in primary and revision breast reconstruction.
  • This submission follows the FDA approval of Motiva implants for breast augmentation on September 27, 2024.
  • Since their breast augmentation approval in 2024, over 60,000 Motiva implants have been sold in the United States.
  • The company aims to extend the benefits of its Motiva technology, which includes the patented SmoothSilk surface and ergonomic design, to women undergoing reconstruction after mastectomy.
Dec 29, 2025, 1:00 PM
Establishment Labs Provides Update on U.S. Market Share, Product Pipeline, and Financial Outlook
ESTA
Guidance Update
Product Launch
Revenue Acceleration/Inflection
  • Establishment Labs anticipates concluding the year with a U.S. market share run rate of approximately 20% and plans to add up to 15 additional sales representatives next year to further drive growth.
  • The company's minimally invasive portfolio, including Mia and the upcoming U.S. launch of Preservae in Q1 next year, is projected to generate $8 million-$10 million from Mia this year and at least $30 million from the combined portfolio next year, significantly expanding the market by attracting new patients.
  • Gross margins surpassed 70% in Q3, an increase from the mid-to-high 60s a year prior, primarily due to higher realized prices in the U.S. market and the higher-margin minimally invasive products.
  • Establishment Labs has achieved EBITDA positive status and aims to be cash flow positive next year, with future investments in commercial operations expected to be at a much lower rate than top-line growth, leading to significant incremental margin drop-through and emerging profitability from late 2026 into 2027 and beyond.
  • The company intends to submit its PMA for the Recon Indication by the end of this year, which could double the U.S. market size and will be followed by a substantial investment in sales force expansion upon approval.
Nov 19, 2025, 8:30 AM
Establishment Labs Provides U.S. Market Update and Future Growth Plans
ESTA
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • Establishment Labs expects to finish the year with a U.S. market share run rate of approximately 20%.
  • The company's minimally invasive portfolio (Mia and Preservae) is projected to generate $8 million-$10 million in 2025 and at least $30 million in 2026.
  • Gross margin crossed 70% in Q3, up from mid-to-high 60s a year ago, driven by the U.S. market mix and higher-margin minimally invasive products.
  • Establishment Labs aims to be cash flow positive next year and expects profitability to emerge as they leave 2026 into 2027 and beyond.
  • A PMA submission for the Recon Indication is planned for the end of this year, which could effectively double the U.S. market size for the company.
Nov 19, 2025, 8:30 AM