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ESTABLISHMENT LABS HOLDINGS (ESTA)

Earnings summaries and quarterly performance for ESTABLISHMENT LABS HOLDINGS.

Recent press releases and 8-K filings for ESTA.

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
Establishment Labs Highlights Strong U.S. Market Penetration and Future Growth Drivers
ESTA
Revenue Acceleration/Inflection
New Projects/Investments
Guidance Update
  • Establishment Labs expects to achieve a 20% U.S. market share run rate by the end of the current year (2025) and anticipates accelerated U.S. growth into 2026, supported by adding up to 15 new sales representatives.
  • The company has become EBITDA positive and aims to be cash flow positive in 2026. Gross margins improved to over 70% in Q3 2025, driven by higher U.S. pricing and minimally invasive products.
  • The minimally invasive portfolio, including Mia and the upcoming U.S. Q1 2026 launch of Preservé, is projected to generate $8 million-$10 million in 2025 and at least $30 million in 2026.
  • A PMA submission for the Recon Indication is planned for the end of 2025, which could double the U.S. market size for the company.
  • The JEM program, a gluteal augmentation pipeline product, is slated for a late 2026/2027 launch in Latin America, with potential to fuel growth from 2028 and beyond.
Nov 19, 2025, 8:30 AM
Establishment Labs Reports Strong Q3 2025 Results, Achieves Positive EBITDA, and Raises Full-Year Guidance
ESTA
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Establishment Labs reported Q3 2025 global revenue of $53.8 million, marking a 34% increase from the previous year, with U.S. revenue at $11.9 million.
  • The company achieved its first quarter of positive Adjusted EBITDA with $1.2 million and surpassed a 70% gross profit margin for the first time, reaching 70.1%.
  • Establishment Labs raised its 2025 revenue guidance to exceed $210 million, an increase from the prior $208-$212 million range, representing at least 26% growth.
  • The U.S. breast augmentation market share is projected to reach approximately 20% by the end of 2025, and the company expects to achieve cash flow positive in 2026.
Nov 5, 2025, 1:30 PM
Establishment Labs Reports Strong Q3 2025 Results and Raises Full-Year Guidance
ESTA
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Establishment Labs Holdings Inc. reported worldwide revenue of $53.8 million for the third quarter ended September 30, 2025, representing a 33.8% increase from the year-ago period.
  • The company achieved positive Adjusted EBITDA of $1.2 million in Q3 2025, an improvement from a loss of $7.0 million in the year-ago period.
  • Management raised its full-year 2025 revenue guidance, now expecting to exceed $210 million, an increase from previous guidance of $208 million to $212 million.
  • The cash balance as of September 30, 2025, was $70.6 million.
Nov 5, 2025, 1:02 PM
Establishment Labs Reports Q3 2025 Financial Results
ESTA
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Establishment Labs reported Q3 2025 worldwide revenue of $53.8 million, representing a 33.8% increase from the year-ago period, and subsequently raised its 2025 revenue guidance to exceed $210 million.
  • The company achieved positive Adjusted EBITDA of $1.2 million in Q3 2025, a notable improvement from a loss of $7.0 million in the prior year period, and reduced its loss from operations to $4.0 million compared to $13.1 million in Q3 2024.
  • As of September 30, 2025, Establishment Labs maintained a cash balance of $70.6 million.
Nov 5, 2025, 1:00 PM
Establishment Labs Highlights Positive Mia Femtech Study Results and 2026 Revenue Projections
ESTA
Product Launch
Guidance Update
New Projects/Investments
  • Establishment Labs announced the publication of positive 3-year prospective study results for its Mia Femtech product, demonstrating a very low complication rate and high patient and surgeon satisfaction.
  • The study reported no capsular contracture (Baker Grade III/IV) or implant rupture, and a 1% reoperation rate at 3 years.
  • The company's CEO expects its minimally invasive platform, which includes Mia Femtech and Preservé, to generate at least $30 million in revenue in 2026.
  • Mia Femtech and Ergonomix2 Diamond implants are available in international markets, while Preservé is available internationally and in limited release in the United States.
Oct 14, 2025, 12:00 PM
Establishment Labs Publishes 2025 Post-Market Surveillance Report
ESTA
Guidance Update
Revenue Acceleration/Inflection
  • Establishment Labs Holdings Inc. announced the publication of its 2025 Post-Market Surveillance (PMS) Report, which includes 15 years of Motiva data.
  • The report indicates less than 1% device-related complications with Motiva implants leading to reoperations, a level of transparency that the company states is unique in the industry.
  • Based on these consistent outcomes, Establishment Labs expressed confidence in its 2025 financial guidance and strong growth in 2026.
  • The company currently has more than two million women worldwide with Motiva implants, with an approximate 400,000 expected to join them next year.
Oct 9, 2025, 12:00 PM
Establishment Labs outlines U.S. expansion & innovation pipeline at Investor Day 2025
ESTA
Guidance Update
Product Launch
  • Strong U.S. momentum with $6.2 M Q1 revenue and expected $9.5–10 M in Q2 sales, positioning US revenue to meaningfully exceed $35 M; over 1,000 surgeons now offer Motiva implants .
  • Full-year 2025 guidance of $205–210 M with plans for EBITDA positive status in 2025 and cash flow positive in 2026, alongside mid-single digit growth ex-U.S. .
  • Pipeline highlights a “super cycle of innovation” with expanded launches of Preservay, MIA, and a planned breast reconstruction implant approval in 2026 (full launch in early 2027) .
  • Upcoming milestones include filing for FDA approval of Motiva implants for reconstruction in Q4 2025 and launching Preservé in the US in H1 2026 .
  • Operational efficiencies have driven a 30% reduction in corporate OPEX since 2023 and gross margin expansion of 200–300 bps, fueled by US growth and minimally invasive product adoption .
Jun 12, 2025, 8:46 PM
Establishment Labs Highlights U.S. Expansion and Pipeline Innovation
ESTA
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
  • The management discussed a differentiated product portfolio that combines strong clinical safety with innovative products, tailored for both global and U.S. markets.
  • Upcoming product launches include Mia, Preservae, and the tissue expander for recon procedures, with a pipeline expected to drive growth over the next 2–3 years.
  • The team emphasized a focused U.S. expansion strategy and operational discipline aimed at margin expansion and profitability improvements.
Jun 4, 2025, 9:36 PM